FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual starting dose in treatment in CML in blast crisis is 600 mg, to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Croatian: Uobičajena početna doza za liječenje KML u blastičnoj krizi iznosi 600 mg, a uzima se jednom na dan kao 6 kapsula od 100 mg (ili 1 kapsula od 400 mg i 2 kapsule od 100 mg).
English: There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
Croatian: U KML bolesnika uočen je veći postotak mijelosupresije nego u bolesnika s GIST-om, što je vjerojatno uzrokovano osnovnom bolešću.
English: Clinical studies in Ph+ ALL
Croatian: Klinička ispitivanja kod Ph+ ALL-a
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 imatiniba u raznim populacijama bolesnika koji pate od bolesti opasnih po život povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
English: The plasma AUC for imatinib decreased by 73 % compared to patients not on EIAEDs.
Croatian: AUC imatiniba u plazmi smanjio se za 73 % u usporedbi s bolesnicima koji nisu primali antiepileptičke lijekove koji induciraju enzime.
English: In the F1 offspring, at the same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased.
Croatian: Pri istoj dozi povećao se broj mrtvorođenih mladunaca, kao i onih koji su uginuli postpartalno između dana 0 i 4. U F1 potomstva, pri istoj dozi, smanjile su se srednje tjelesne težine od poroda sve do konačnog žrtvovanja, a broj okota koji su postigli kriterij za prepucijsku separaciju bio je malo smanjen.
English: 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.
Croatian: U ispitivanju fertilnosti, u mužjaka štakora koji su primali dozu tijekom 70 dana prije parenja, smanjila se težina testisa i epididimisa te postotak pokretljive sperme uz dozu od 60 mg/kg, što je približno jednako maksimalnoj kliničkoj dozi od 800 mg/dan, temeljeno na veličini površine tijela.
English: This will help protect you from stomach problems when
Croatian: To će Vam pomoći u zaštiti od želučanih problema prilikom uzimanja Imatinib medaca.
English: Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30 % (9 % complete) and a major cytogenetic response rate of 23 %.
Croatian: Recidivirajući ili refraktorni Ph+ ALL: Kada je imatinib samostalno korišten u bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om, rezultirao je s odgovorom u 53 od 411 procijenjenih bolesnika, sa stopom hematološkog odgovora od 30 % (9 % potpuni) i stopom većeg citogenetskog odgovora od 23 %.
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Croatian: Hipokalijemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija, giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatrijemija
English: The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Croatian: Doza se može smanjiti ako se ne podnosi (vidjeti dijelove 4.2 i 5.2).
English: Population pharmacokinetics
Croatian: Farmakokinetika populacije
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.
Croatian: Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti Imatinib povećava srednju vrijednost Cmax i AUC simvastatina (CYP3A4 supstrat) za 2, odnosno 3,5 puta, što ukazuje na to da imatinib inhibira CYP3A4.
English: Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib.
Croatian: Bolesnike treba obavijestiti o postojanju mogućnosti da tijekom liječenja imatinibom nastupe nuspojave poput omaglice, zamagljenog vida ili somnolencije.
English: Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.
Croatian: Kronična mijeloična leukemija je oblik leukemije u kojem određene abnormalne bijele krvne stanice (zvane mijeloidne stanice) počinju nekontrolirano rasti.
English: Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Croatian: Hipertenzija, hematom, subduralni hematom, periferna hladnoća, hipotenzija, Raynaudov fenomen
English: Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with 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.
Croatian: Povećanja doze od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s blastičnom krizom može se razmotriti u odsutnosti teške nuspojave i teške neutropenije ili trombocitopenije nepovezane 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: MARKETING AUTHORISATION NUMBER (S) EU/1/13/876/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/876/001
English: Do not take Imatinib medac: • if you are allergic to imatinib or any of the other ingredients of this medicine (listed in
Croatian: • ako ste alergični na imatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: There is no experience in children or adolescents with HES/CEL.
Croatian: Nema iskustva s HES/KEL-om u djece ili adolescenata.
English: Resume treatment with imatinib at 600 mg.
Croatian: 2. Ponovno uvesti liječenje imatinibom u dozi od 600 mg.
English: • Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
Croatian: • bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice, omaglica ili nesvjestica zbog sniženog krvnog tlaka (znakovi problema s jajnicima ili maternicom)
English: 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.
Croatian: Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i ne-žljezdani želudac.
English: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation,
Croatian: 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: No evidence of leukaemia (NEL) Return to chronic phase (RTC) Major cytogenetic response Complete (Confirmed
Croatian: Hematološki odgovor Potpuni hematološki odgovor (CHR) Nema dokaza leukemije (NEL) Vraćanje na kroničnu fazu (RTC) Veliki citogenetski odgovor2 Potpuni (Potvrđeni3) [95 % CI]
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg.
Croatian: 2. Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 400 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.
Croatian: Prije početka liječenja bolesnika s pozitivnim serološkim nalazima na hepatitis B (uključujući one s aktivnom bolešću) te za bolesnike za koje se pokaže da su pozitivni na HBV tijekom liječenja, potrebno je savjetovati se sa stručnjacima za bolesti jetre i liječenje hepatitisa B.
English: You may feel dizzy or drowsy or get blurred vision while taking this medicine.
Croatian: Tijekom uzimanja ovog lijeka možete osjetiti omaglicu ili imati zamagljen vid.
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
Croatian: U bolesnika u kojih je obavljena tireoidektomija i koji primaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena kada se istodobno primjenjuje imatinib (vidjeti dio 4.4).
English: There are limited data on the use of imatinib in pregnant women.
Croatian: Podaci o primjeni imatiniba u trudnica su ograničeni.
English: The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
Croatian: Početna doza je 100 mg, a uzima se kao 1 kapsula od 100 mg jednom na dan.
English: The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and ALL patients.
Croatian: Supstancija selektivno inhibira proliferaciju te inducira apoptozu u Bcr-Abl pozitivnim staničnim linijama, kao i u svježim leukemijskim stanicama osoba koje boluju od kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom i od akutne limfoblastične leukemije (ALL).
English: Dose increases from 340 mg/m daily to 570 mg/m daily (not to exceed the total dose of 800 mg) 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.
Croatian: Povećanja doze od 340 mg/m² na dan do 570 mg/m² na dan (ne smije se prekoračiti ukupna doza od 800 mg) mogu se razmotriti u odsutnosti teške nuspojave i teške neutropenije ili trombocitopenije nepovezane 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: • Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of
Croatian: • grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi mišićnih problema)
English: Posology modification
Croatian: Promjene doziranja
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage
Croatian: Stomatitis, ulceracija u ustima, gastrointestinalno krvarenje
English: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Croatian: Aritmija, fibrilacija atrija, srčani zastoj, infarkt miokarda, angina pektoris,
English: Vertigo, tinnitus, hearing loss
Croatian: Vrtoglavica, tinitus, gubitak sluha
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Croatian: Poboljšanja su zabilježena u srčanom, živčanom, koži/potkožnom tkivu, dišnom/prsištu/sredoprsju, mišićno-koštanom/vezivnom tkivu/krvožilnom i probavnom organskom sustavu.
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Croatian: U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL-om liječeno je imatinibom od 100 mg do 1000 mg na dan.
English: Imatinib medac is indicated for the treatment of
Croatian: Imatinib medac indiciran je za liječenje
English: Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Croatian: Migrena, pospanost, sinkopa, periferna neuropatija, poremećaj pamćenja, ishijalgija, sindrom nemirnih nogu, tremor, cerebralno krvarenje
English: 1) Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
Croatian: 1) Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s GIST-om.
English: Imatinib medac contains lactose.
Croatian: Imatinib medac sadrži laktozu.
English: Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity
Croatian: Svrbež, edem lica, suhoća kože, eritem, alopecija, noćno znojenje, reakcija preosjetljivosti na svjetlo
English: Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81 % of the dose was recovered within 7 days in faeces (68 % of dose) and urine (13 % of dose).
Croatian: C-označene doze imatiniba, oko 81 % doze izlučilo se u roku od 7 dana u stolici (68 % doze) i mokraći (13 % doze).
English: Posology for HES/CEL in adult patients
Croatian: Doziranje za HES/KEL u odraslih bolesnika
English: Palpitations, tachycardia, cardiac failure congestive 3, pulmonary oedema
Croatian: Palpitacije, tahikardija, kongestivno zatajenje srca3, plućni edem
English: No significant age-related pharmacokinetic differences have been observed in patients in clinical trials which included over 20 % of patients aged 65 and older.
Croatian: U kliničkim ispitivanjima koja su uključivala preko 20 % bolesnika u dobi od 65 godina i više, nisu zapažene značajne farmakokinetičke razlike vezane uz dob.
English: Active substances that may increase imatinib plasma concentrations 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.
Croatian: Djelatne tvari koje mogu povećati koncentracije imatiniba u plazmi Tvari koje inhibiraju djelovanje CYP3A4 izoenzima citokroma P450 (npr. inhibitori proteaze kao što su indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotici uključujući ketokonazol, itrakonazol, posakonazol, vorikonazol; određeni makrolidi kao što su eritromicin, klaritromicin i telitromicin) mogle bi smanjiti metabolizam i povećati koncentracije imatiniba.
English: If any of these apply to you, tell your doctor before taking Imatinib medac.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Imatinib medaca.
English: How much Imatinib medac to take
Croatian: Koliko Imatinib medaca uzeti
English: Treatment of CML patients with imatinib has been associated with neutropenia or thrombocytopenia.
Croatian: Liječenje imatinibom je kod bolesnika s KML-om povezano s neutropenijom ili trombocitopenijom.
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Croatian: Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) koje je uključivalo 12 bolesnika s DFSP-om liječenih imatinibom od 800 mg na dan.
English: Imatinib medac 100 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Croatian: Imatinib medac 100 mg tvrde kapsule PA-aluminij/PVC/aluminij blisteri.
English: • Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of
Croatian: • mučnina uz gubitak apetita, tamno obojena mokraća, žutilo kože ili očiju (znakovi problema s jetrom)
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 10
Croatian: 4. Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve dok ABN ne bude ≥1 x 109/i trombociti ≥20 x 10
English: Maintenance (8-week cycles) Cycles 1-4
Croatian: (8-tjedni ciklusi) Ciklusi 1-4
English: INFORMATION IN BRAILLE Imatinib medac 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Imatinib medac 100 mg
English: Posology for Ph+ ALL in children
Croatian: Doziranje za Ph+ ALL u djece
English: Liver function tests
Croatian: Poremećaj funkcije jetre Testovi funkcije jetre Blagi
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Croatian: U obje su vrste zapažena blaga do umjerena povećanja razine transaminaza, te mala smanjenja razina kolesterola, triglicerida, ukupnih proteina i albumina.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m 3.
Croatian: 2. Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 260 mg/m².
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
Croatian: Potreban je oprez kada se imatinib uzima s inhibitorima proteaze, azolnim antimikoticima, određenim makrolidima (vidjeti dio 4.5), CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel, kinidin) ili varfarinom i drugim derivatima kumarina (vidjeti dio 4.5).
English: Imatinib medac 400 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Croatian: Imatinib medac 400 mg tvrde kapsule PA-aluminij/PVC/aluminij blisteri.
English: Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Croatian: Pleuralna bol, plućna fibroza, plućna hipertenzija, plućno krvarenje
English: As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Croatian: Budući da su srčane nuspojave zabilježene manje često uz imatinib, prije početka liječenja u HES/KEL populaciji potrebno je uzeti u obzir pažljivu procjenu omjera koristi i rizika od terapije imatinibom.
English: Imatinib medac is also a treatment for adults for:
Croatian: Imatinib medac se također koristi kod odraslih osoba za liječenje:
English: 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,
Croatian: Zbog toga se preporučuje oprezno postupati kada se imatinib primjenjuje s CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel i kinidin).
English: • adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Croatian: • odraslih bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om u obliku monoterapije,
English: Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n = 11) or CML in blast crisis or Ph+ acute leukaemias (n = 15) were enrolled in a dose-escalation phase I trial.
Croatian: <18 godina bilo s kroničnom fazom KML-a (n=11), bilo s KML-om u blastičnoj krizi ili Ph+ akutnim leukemijama (n=15).
English: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) ili česte (mogu se javiti u do 1 na 10 osoba):
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Croatian: • odraslih i pedijatrijskih bolesnika s novodijagnosticiranom akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) uz kemoterapiju,
English: For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Croatian: Bolesnicima koji ne mogu progutati filmom obložene kapsule, sadržaj kapsule može se otopiti u čaši negazirane vode ili soka od jabuke.
English: Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Croatian: Teška jetrena toksičnost zapažena je u pasa koji su liječeni 2 tjedna, uz povišene jetrene enzime, hepatocelularnu nekrozu, nekrozu žučnih vodova te hiperplaziju žučnih vodova.
English: This inhibition has not been observed in vivo after 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: Imatinib medac contains lactose monohydrate
Croatian: Imatinib medac sadrži laktozu hidrat
English: There are no controlled trials in paediatric patients with HES/CEL.
Croatian: Nema kontroliranih ispitivanja u pedijatrijskih bolesnika s HES/KEL-om.
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis
Croatian: Akutna febrilna neutrofilna dermatoza (Sweetov sindrom), promjena boje nokta, angioedem, vezikularni osip, multiformni eritem, leukocitoklastični vaskulitis, Stevens-Johnsonov sindrom, akutna generalizirana egzantematozna pustuloza (AGEP)
English: MTX 15 mg intrathecal, days 1, 8, 15, 22;
Croatian: MTX 15 mg intratekalno, dani 1, 8, 15, 22;
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Croatian: Metotreksat (20 mg/m²/tjedan, p.o.): dani 8, 15, 22, 29, 36, 43, 50
English: 10) Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Croatian: 10) Mišićno-koštana bol i srodni događaji češće su uočeni u bolesnika s KML-om nego u bolesnika s GIST-om.
English: 9/l and platelets ≥ 20 x 10
Croatian: 9/l, a trombociti ≥20 x 10
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Posology for CML in paediatric patients Dosing for paediatric patients should be on the basis of body surface area (mg/m2).
Croatian: U pedijatrijskih bolesnika doziranje se treba temeljiti na veličini površine tijela (mg/m²).