FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Croatian: Manje često Hipokalemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija, giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatremija
English: The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Croatian: Početna doza je 100 mg, a uzima se jedna tableta od 100 mg jednom dnevno.
English: Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders
Croatian: Nepoznato Akutno zatajenje disanja11*, intersticijska plućna bolest* Poremećaji probavnog sustava
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
Croatian: Manje često Pustularni osip, kontuzije, pojačano znojenje, urtikarija, ekhimoza, povećana sklonost modricama, hipotrihoza, hipopigmentacija kože, eksfolijativni dermatitis, onihoklazija, folikulitis, petehije, psorijaza, purpura, hiperpigmentacija kože, bulozne erupcije
English: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Croatian: Aritmija, fibrilacija atrija, srčani zastoj, infarkt miokarda, angina pektoris, perikardijalna efuzija Nepoznato Perikarditis*, tamponada srca* Krvožilni poremećaji4
English: • 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).
Croatian: • mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcijate niske razine fosforau krvi).
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR
Croatian: Ista publikacija je objavila i podatke dugotrajnog praćenja od 12 MDS/MPD bolesnika s preraspodjelom PDGFR gena (5 bolesnika iz studije B2225).
English: INFORMATION IN BRAILLE Imatinib Accord 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Imatinib Accord 100 mg
English: INFORMATION IN BRAILLE Imatinib Accord 400 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Imatinib Accord 400 mg
English: How long to take Imatinib Accord
Croatian: Koliko dugo uzimati Imatinib Accord
English: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), 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).
Croatian: Potreban je oprez kada seimatinib uzima sinhibitorima proteaze, azolnim antimikoticima, određenim makrolidima (vidjeti dio 4.5), CYP3A4 supstratima s uskom terapijskom širinom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel, kvinidin) ilivarfarinomi drugimderivatimakumarina (vidjeti dio 4.5).
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1 x 109/1 and platelets ≥ 20 x 109/1, then resume treatment at 300 mg.
Croatian: Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu Imatinib Accorda sve dok ABN ne bude  1 x 109/l i trombociti  20 x 109/l, nakon toga nastaviti liječenje u dozi od 300 mg.
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.
Croatian: Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) za ispitivanje imatinibom u raznim populacijama bolesnika koji pate od bolesti opasnih po život povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
English: Relapsed/refractory Ph+ ALL
Croatian: Recidivirajući ili refraktorni Ph+ ALL
English: Active substances that may increase imatinib plasma concentrations
Croatian: Djelatne tvari koje mogu povećati koncentracije imatiniba u plazmi:
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Croatian: MESNA (360 mg/m2/doza svaka 3 sata x 8 doza/dan, i.v.): dani 1-5 G-CSF (5 μg/kg, s.c.): dani 6-15 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti i.t. metotreksat (prilagođeno dobi): SAMO dan 1
English: Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
Croatian: U patogenezu MDS/MPD-a, HES/KEL-a i DFSP-a uključena je ili konstitutivna aktivacija receptora za PDGF ili Abl proteintirozin kinaza koja nastaje kao posljedica fuzije za različite partnerske proteine ili konstitutivno stvaranje PDGF-a.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1x109/1 and platelets ≥ 20x109/1, then resume treatment at 200 mg/m2.
Croatian: Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu Imatinib Accorda sve dok ABN ne bude 1 x 109/i trombociti  20 x 109/l, nakon toga nastaviti liječenje u dozi od 200 mg/m2.
English: • Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
Croatian: • blijeda koža, umor i gubitak daha te tamno obojena mokraća (znakovi snižene razine crvenih krvnih stanica).
English: • Feeling dizzy or weak.
Croatian: • omaglica ili slabost.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Croatian: Nepoznato Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)* , pseudoporfirija* Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često
English: Active substances that may decrease imatinib plasma concentrations
Croatian: Djelatne tvari koje mogu smanjiti koncentracije imatiniba u plazmi:
English: Partial Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): CHR: Study 0110 [WBC < 10 x 109/l, platelets < 450 x 109/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 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 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).
Croatian: 1 Kriteriji hematološkog odgovora (svi se odgovori moraju potvrditi nakon ≥4 tjedna): CHR: Studija 0110 [WBC < 10 x 109/l, trombociti < 450 x 109/l, mijelociti+metamijelociti <5% u krvi, u krvi nema blasta i promijelocita, bazofili < 20%, nema ekstramedularne zahvaćenosti], a u studijama 0102 i 0109 [ABN ≥ 1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u KS <5% i nema ekstramedularne bolesti]
English: Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Croatian: Bolesnici zabrinuti radi svoje plodnosti tijekom liječenja Imatinib Accordom moraju se posavjetovati sa svojim liječnikom.
English: doses)iii: days 2 and 3
Croatian: 6 doza) iii: dani 2 i 3
English: Resume treatment with Imatinib Accord at 600 mg.
Croatian: Ponovno uvesti liječenje Imatinib Accordom u dozi od 600 mg.
English: Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).
Croatian: U slučajevima kada se imatinib kombinira s režimima kemoterapije za koje je poznato da su povezani s poremećajem funkcije jetre potrebno je pažljivo praćenje jetrene funkcije (vidjeti dijelove 4.5 i 4.8).
English: • Swelling such as round your ankles or puffy eyes.
Croatian: • oticanje kao što je oticanje gležnjeva ili otečene oči.
English: Hypromellose 6 cps (E464) Talc (E553b)
Croatian: Hipromeloza 6 cps (E464) talk (E553b) polietilenglikol željezov oksid, žuti (E172)
English: Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Croatian: Trajanje liječenja: u jedinom kliničkom ispitivanju provedenom do sada, liječenje imatinibom je nastavljeno do progresije bolesti (vidjeti dio 5.1).U vrijeme analize, medijan trajanja liječenja bio je 47 mjeseci (24 dana-60 mjeseci).
English: Avascular necrosis/hip necrosis*, growth retardation in children and adolescents* Renal and urinary disorders
Croatian: Nepoznato Avaskularna nekroza/nekroza kuka*, zastoj u rastu kod djece i adolescenata* Poremećaji bubrega i mokraćnog sustava
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Croatian: Manje često Stomatitis, ulceracija u ustima, gastrointestinalno krvarenje7, podrigivanje, melena, ezofagitis, ascites, želučani ulkus, hematemeza, heilitis, disfagija, pankreatitis
English: Maintenance (8-week cycles) Cycles 1cy
Croatian: Održavanje (8-tjedni ciklusi) Ciklusi 1-4
English: • Severely decreased urine output, feeling thirsty (signs of kidney problems).
Croatian: • jako smanjeno mokrenje, osjećaj žeđi (znakovi bubrežnih problema).
English: Imatinib Accord is also a treatment for children and adolescents with CML.
Croatian: Accord se kod djece i adolescenata također koristi za liječenje KML-a.
English: DEX 10 mg/ m2 oral, days 1-5;
Croatian: DEX 10 mg/m2peroralno, dani 1-5;
English: Active substances that may have their plasma concentration altered by imatinib
Croatian: Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti
English: • Pain or swelling in your abdomen, flatulence, heartburn or constipation.
Croatian: • bol ili oticanje u trbuhu, vjetrovi, žgaravica ili zatvor.
English: Imatinib Accord is a treatment for adults for:
Croatian: Accord se kod odraslih osoba koristi za liječenje:
English: Pleural effusion5, pharyngolaryngeal pain, pharyngitis
Croatian: Manje često Pleuralni izljev5, faringolaringealna bol, faringitis Rijetko
English: 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.
Croatian: Tvari koje induciraju djelovanje CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ili Hypericum perforatum, poznat također kao gospina trava) mogu značajno smanjiti izloženost imatinibu, čime se potencijalno povećava rizik od neuspjeha terapije.
English: VCR 1.3 g/ m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
Croatian: VCR 1,3 g/m2 i.v., dan 1; Prednizolon 60 mg/m2peroralno, dani 1-5
English: Hyperbilirubinaemia, hepatitis, jaundice
Croatian: Manje često Hiperbilirubinemija, hepatitis, žutica Rijetko
English: Stop Imatinib Accord until ANC ≥ 1.5x109/1 and platelets ≥ 75x109/1.
Croatian: Ukinuti Imatinib Accord sve dok ABN ne bude  1,5 x 109/l i trombociti 75 x 109/l.
English: How much Imatinib Accord to take
Croatian: Koliko Imatinib Accorda uzeti
English: • Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
Croatian: • teška bol u trbuhu, krv u sadržaju povraćanja, stolici ili mokraći, crne stolice (znakovi probavnih problema).
English: Newly diagnosed Ph+ ALL
Croatian: Novodijagnosticirani Ph+ ALL
English: Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Croatian: Omaglica, parestezija, poremećaj okusa, hipoestezija Manje često Migrena, pospanost, sinkopa, periferna neuropatija, poremećaj pamćenja, ishijalgija, sindrom nemirnih nogu, tremor, cerebralno krvarenje
English: • Bruising.
Croatian: • svrbež.
English: 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.
Croatian: (ne smije se prekoračiti ukupna doza od 800 mg) u odsustvu teške nuspojave na lijek i teške neutropenije ili trombocitopenije nepovezanih s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3, 4, 5;
Croatian: DEX 10 mg/m2peroralno, dani 1-5; CP 200 mg/m2 i.v., dani 3, 4, 5;
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: 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.
Croatian: Doza je 800 mg na dan, koja se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg ujutro i 4 tablete od 100 mg ili 1 tableta od 400 mg navečer.
English: • Painful and/or blistering skin lesions.
Croatian: • lezije (oštećenja) kože koje su bolne i/ili s mjehurićima.
English: Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Croatian: Manje često Ginekomastija, erektilna disfunkcija, menoragija, nepravilne mjesečnice, poremećaj seksualne funkcije, bol u bradavicama, povećanje dojki, edem skrotuma
English: Very common Weight increased Common
Croatian: Povećana tjelesna težina
English: Thisinhibition has not been observed in vivoafter the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Croatian: Ovakva inhibicija nije uočena in vivo nakon primjene imatiniba u dozi od 400 mg i paracetamola u dozi od 1000 mg.
English: Maintenance (8-week cycles) Cycle 5
Croatian: Održavanje (8-tjedni ciklusi)
English: • Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
Croatian: • mučnina s proljevom i povraćanjem, bol u trbuhu ili vrućica (znakovi crijevnih problema).
English: Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Croatian: Manje često Iritacija oka, bol u oku, orbitalni edem, krvarenje bjeloočnice, krvarenje mrežnice, blefaritis, makularni edem
English: Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
Croatian: U 4 publikacije zabilježeno je 5 bolesnika s MDS/MPD-om povezanim s preraspodjelom gena za PDGFR.
English: How to take Imatinib Accord
Croatian: Kako uzimati Imatinib Accord
English: Musculoskeletal and connective tissue disorders Very common Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia,
Croatian: Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju9, artralgiju, bol u kostima10
English: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Croatian: Manje često Palpitacije, tahikardija, kongestivno zatajenje srca3, plućni edem Rijetko
English: 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.
Croatian: Ovisno o Vašem stanju, uobičajena početna doza je ili 400 mg ili 600 mg: 400 mg se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg jednom na dan.
English: Methylprednisolone 40 mg intrathecal, day1
Croatian: Metilprednizolon 40 mg intratekalno, dan 1
English: Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Croatian: - Akutne limfoblastične leukemije s pozitivnim Philadelphia kromosomom (Ph-pozitivni ALL).
English: 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.
Croatian: Imatinib Accord 400 mg filmom obložene tablete su smećkastonarančaste, ovalne, bikonveksne filmom obložene tablete s utisnutom oznakom „IM“ s jedne strane razdjelne crte i oznakom „T2“ s druge strane razdjelne crte te bez oznaka na drugoj strani tablete.
English: Increased intracranial pressure, convulsions, optic neuritis
Croatian: Povišen intrakranijalni tlak, konvulzije, optički neuritis Nepoznato Cerebralni edem* Poremećaji oka
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis,cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Croatian: Manje često Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis,
English: Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Croatian: Kada se imatinib primjenjuje s inhibitorima obiteljiCYP3A4, potrebno je oprezno postupati.
English: CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Croatian: CPM (250 mg/m2/doza svakih 12 sati x 4 doze, i.v.): Dani 3 i 4 PEG-ASP (2500 IU/m2, i.m.): dan 4
English: • Joint pain with swelling.
Croatian: • bolovi u zglobovima s oticanjem.
English: Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications.
Croatian: U 3 publikacije zabilježena su 3 bolesnika s HES-om i KEL-om povezanim s preraspodjelom gena za PDGFR.
English: G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Croatian: G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti
English: of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Croatian: Na temelju izlučivanja spoja(eva) nakon oralne 14C-označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
English: ANC < 1.0x109/l and/or platelets < 50 x 109/l
Croatian: ABN <1,0 x 109/l i/ili trombociti <50 x 109/l
English: Imatinib Accord 400 mg tablets
Croatian: Imatinib Accord 400 mg tablete
English: 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.
Croatian: Imatinib Accord100 mg filmom obložene tablete su smećkastonarančaste, okrugle, bikonveksne filmom obložene tablete s utisnutom oznakom „IM“ s jedne strane razdjelne crte i oznakom „T1“ s druge strane razdjelne crte te bez oznaka na drugoj strani tablete.
English: Imatinib Accord 100 mg tablets
Croatian: Imatinib Accord 100 mg tablete
English: Reproductive system and breast disorders Uncommon
Croatian: Poremećaji reproduktivnog sustava i dojki
English: 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.
Croatian: U slučaju da je ABN ponovno < 1,0 x 109/l i/ili trombociti < 50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu Imatinib Accorda u smanjenoj dozi od 300 mg.
English: • Difficulty hearing.
Croatian: • oslabljen sluh.
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Croatian: Ara-C 40 mg intratekalno, dani 1, 8, 15, 22;
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Croatian: Kad se stopa odgovora računa u bolesnika s barem jednom valjanom procjenom, stopa odgovora za CHR, CCyR i MR bila je 20/22
English: All patients achieved complete haematological response, cytogenetic response and/or clinical response.
Croatian: citogenetski odgovor i/ili klinički odgovor.
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)* Hepatobiliary disorders Common
Croatian: Nepoznato Ileus/intestinalna opstrukcija*, gastrointestinalna perforacija*, divertikulitis*,
English: Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered.
Croatian: Prije primjene imatiniba u bolesnika s HES/KEL-om i u bolesnika s MDS/MPD-om povezanim s visokim razinama eozinofila potrebno je razmisliti o pregledu kod specijaliste kardiologa, obavljanje ehokardiograma i određivanje serumskog troponina.
English: Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
Croatian: U 3 publikacije zabilježeno je 5 bolesnika s DFSP-om i preraspodjelom PDGFR gena.
English: 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.
Croatian: U slučaju da je ABN ponovno < 1,0 x109/l i/ili trombociti < 50 x109/l, treba ponoviti 1. korak i nastaviti primjenu Imatinib Accorda u smanjenoj dozi od 260 mg/m2.
English: In paediatric CML patients the most frequent toxicities observed were grade3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Croatian: U pedijatrijskih KML bolesnika najčešće uočene toksičnosti bile su citopenije 3. ili
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Croatian: ARA-C (3 g/m2, svakih 12 sati, i.v.): dani 43, 44
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x
Croatian: Metotreksat (5 g/m2 kroz 24 sata, i.v.): dani 1 i 15 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x
English: • Chronic renal failure
Croatian: • kronično zatajenje bubrega
English: The recommended dose of Imatinib is 800 mg/day for adult patients with DFSP.
Croatian: Za odrasle bolesnike DFSP-om preporučena doza imatiniba iznosi 800 mg/dan.
English: • Mouth ulcers.
Croatian: • čirevi u ustima.
English: Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Croatian: Jedna filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: A total of 1,106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Croatian: Ukupan broj od 1106 bolesnika je randomiziran po 553 ispitanika u svaki krak.