FrancophonIA/ELRC3.0 huggingface dataset:
English: Thereafter, treatment can be resumed as appropriate depending on the initial severity
Croatian: Nakon toga se liječenje može nastaviti ovisno o početnoj
English: - The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow
Croatian: - Ovojnica tablete sastoji se od polivinilnog alkohola djelomično hidroliziranog, makrogola,
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Croatian: divertikulitis*, gastrična antralna vaskularna ektazija (GAVE)*
English: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase
Croatian: Povišen kreatinin u krvi, povišena kreatin-fosfokinaza u krvi, povišena laktatdehidrogenaza u krvi, povišena alkalna fosfataza u krvi
English: The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Croatian: Ukupna dnevna doza u djece i adolescenata ne smije prijeći 800 mg kod KML-a i 600 mg kod Ph+ALL-a.
English: In this patient population, the presence of hepatic metastases could potentially lead to hepatic insufficiency and reduced metabolism.
Croatian: U toj bi populaciji bolesnika prisutnost metastaza u jetri mogla potencijalno dovesti do jetrene insuficijencije i
English: Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Croatian: Imatinib u kombinaciji s indukcijskom kemoterapijom (vidjeti Tablicu 3) rezultira postizanjem stope kompletnog hematološkog odgovora od 93% (147 od 158 evaluiranih bolesnika) i stope velikog citogenetskog odgovora od 90% (19 od 21 evaluiranog bolesnika).
English: Study 0102 38-month data Myeloid blast crisis (n=260)
Croatian: Studija 0102 38-mjesečni podaci Mijeloična blastična kriza
English: They may increase or decrease the effect of Imatinib Teva B.V., either leading to increased side effects or making Imatinib Teva B.V. less effective.
Croatian: Oni mogu povećati ili smanjiti učinak Imatiniba Teva B.V. bilo povećanjem nuspojava ili smanjenjem učinka Imatiniba Teva B.V.
English: • Chest pain, irregular heart rhythm (signs of heart problems).
Croatian: • Bol u prsnom košu, nepravilan srčani ritam (znakovi srčanih problema).
English: 1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Croatian: 1800 mg do 3200 mg (najviše 3200 mg na dan tijekom 6 dana): slabost, mialgija, povišenje vrijednosti kreatinin fosfokinaze, povišenje vrijednosti bilirubina, bol u trbuhu.
English: What you need to know before you take Imatinib Teva B.V.
Croatian: Što morate znati prije nego počnete uzimati Imatinib Teva B.V.
English: Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Croatian: Liječenje imatinibom izazvalo je brzi odgovor pedijatrijskih bolesnika s novodijagnosticiranim KML-om sa CHR-om od 78% nakon 8 tjedana terapije.
English: Keep taking Imatinib Teva B.V. every day for as long as your doctor tells you.
Croatian: Imatinib Teva B.V. nastavite uzimati svaki dan onoliko dugo koliko Vam je liječnik rekao.
English: • The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Croatian: • Liječenje odraslih bolesnika s Kit (CD 117) pozitivnim inoperabilnim i/ili metastazirajućim malignim gastrointestinalnim stromalnim tumorima (GIST).
English: The primary endpoint of the study was recurrence-free survival (RFS), defined as the time from date of randomisation to the date of recurrence or death from any cause.
Croatian: Primarni ishod ispitivanja bio je preživljenje bez recidiva bolesti, definirano kao vrijeme od datuma randomizacije do datuma recidiva ili smrti zbog bilo kojeg uzroka.
English: After resection of primary GIST, patients were randomised to one of the two arms: imatinib at 400 mg/day or matching placebo for one year.
Croatian: Nakon resekcije primarnog GIST-a, bolesnici su randomizirani u jedan od dva kraka: imatinib 400 mg/dan ili odgovarajući placebo tijekom jedne godine.
English: In patients with GIST steady-state exposure was 1.5-fold higher than that observed for CML patients for the same dosage (400 mg daily).
Croatian: U bolesnika s GIST-om izloženost u stanju dinamičke ravnoteže bila je 1,5 puta veća od one koja je zapažena u bolesnika s KML-om uz isto doziranje (400 mg na dan).
English: Imatinib Teva B.V. inhibits the growth of these cells in a certain subtype of these diseases.
Croatian: Imatinib Teva B.V. inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.
English: Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
Croatian: U 7 publikacija zabilježeno je sedamnaest (17) bolesnika s GIST-om (sa ili bez Kit ili PDFGR mutacija).
English: Events that have been reported at different dose ranges are as follows:
Croatian: Zabilježeni su sljedeći događaji u različitim
English: The content of the capsule is white to light yellow granulated powder.
Croatian: Sadržaj kapsule je granulirani prašak bijele
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
Croatian: Bolesnike sa srčanom bolešću, faktorom rizika za zatajenje srca ili ranijim zatajenjem bubrega treba pažljivo pratiti, a svakog bolesnika sa znakovima ili simptomima koji ukazuju na zatajenje srca ili bubrega treba obraditi i liječiti.
English: The effect of stopping treatment after the achievement of a complete cytogenetic response has not been
Croatian: Učinak prekida liječenja nakon postizanja potpunog citogenetskog odgovora nije ispitivan.
English: Tlf: +47 66 77 55 90
Croatian: Teva Norway AS Tlf: +47 66 77 55 90
English: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Imatinib Teva B.V.: - ako ste alergični na imatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Other medicines and Imatinib Teva B.V.
Croatian: Drugi lijekovi i Imatinib Teva B.V.
English: NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l 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.
Croatian: NEL Isti kriteriji kao za CHR, ali je ABN ≥1 x 109/l, a trombociti ≥20 x 109/l RTC <15% blasta u KS i PK, <30% blasta+promijelocita u KS i PK, <20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri
English: The ages of these patients ranged from 18 to 91 years.
Croatian: Dob tih bolesnika se kretala od 18 do 91 godine.
English: Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Croatian: Insuficijencija jetre: Imatinib se većinom metabolizira preko jetre.
English: Patients were included who had a histological diagnosis of primary GIST expressing Kit protein by immunochemistry and a tumour size ≥ 3 cm in maximum dimension, with complete gross resection of primary GIST within 14-70 days prior to registration.
Croatian: Uključeni bolesnici imali su histološku dijagnozu primarnog GIST-a s imunokemijski dokazanom ekspresijom Kit proteina i veličinom tumora ≥3 cm u najvećem promjeru, uz potpunu makroskopsku resekciju primarnog GIST-a unutar 14-70 dana prije uključivanja u ispitivanje.
English: If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
Croatian: Ako je bilo što od navedenog abnormalno, na početku terapije je potrebno razmisliti o profilaktičkoj primjeni sistemskih steroida (1-2 mg/kg) tijekom jednog do dva tjedna istodobno uz imatinib te redovitim kardiološkim
English: Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides
Croatian: Potreban je oprez kada se imatinib uzima s inhibitorima proteaze, azolnim antimikoticima,
English: One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count
Croatian: Kod jednog trogodišnjeg dječaka izloženog jednokratnoj dozi od 400 mg došlo je do povraćanja, proljeva i anoreksije, dok je kod drugog trogodišnjeg dječaka izloženog jednokratnoj dozi od 980 mg došlo do smanjenog broja leukocita i proljeva.
English: Imatinib administration to patients without the genetic translocation generally results in no
Croatian: Primjena imatiniba bez genetske translokacije obično ne rezultira poboljšanjem.
English: In the adjuvant setting, imatinib was investigated in a multicentre, double-blind, long-term, placebocontrolled phase III study (Z9001) involving 773 patients.
Croatian: U sklopu adjuvantnog liječenja, imatinib je ispitivan u multicentričnom, dvostrukoslijepom, dugotrajnom placebo kontroliranom ispitivanju faze III (Z9001) koje je uključivalo 773 bolesnika.
English: Imatinib Teva B.V. may do the same to some other
Croatian: Imatinib Teva B.V. može to isto napraviti nekim drugim
English: , Ελλάδα Τηλ: +30 210 72 79 099
Croatian: Τηλ: +30 210 72 79 099
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent
Croatian: Vezanje N-demetiliranog metabolita za bjelančevine plazme je slično onom
English: - Gastrointestinal stromal tumours (GIST).
Croatian: - Gastrointestinalnih stromalnih tumora (GIST).
English: Imatinib Teva B.V. is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Croatian: Imatinib Teva B.V. se kod odraslih osoba također koristi za liječenje: - Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
English: What Imatinib Teva B.V. looks like and contents of the pack
Croatian: Kako Imatinib Teva B.V. izgleda i sadržaj pakiranja
English: A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day imatinib 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter > 5 cm and mitotic count > 5/50 high power fields (HPF); or tumour diameter > 10 cm and any mitotic count or tumour of any size with mitotic count > 10/50 HPF or tumours ruptured into the peritoneal cavity.
Croatian: Drugo otvoreno multicentrično ispitivanje faze III (SSG XVIII/AIO) uspoređivalo je 12 mjeseci liječenja imatinibom 400 mg/dan u odnosu na 36 mjeseci liječenja u bolesnika nakon kirurške resekcije GIST-a i jednog od sljedećeg: promjer tumora >5 cm i broj mitoza >5/50 u vidnom polju mikroskopa pri velikom povećanju (HPF, engl. high power fields); ili promjer tumora >10 cm i bilo koji broj mitoza ili tumor bilo koje veličine s brojem mitoza >10/50 HPF ili ruptura tumora u peritonealnu šupljinu.
English: Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs.
Croatian: Stalna svakodnevna izloženost imatinibu u ranoj fazi liječenja u kombinaciji s kemoterapijom dovela je u bolesnika iz kohorte 5 (n=50) do poboljšanja stope 4-godišnjeg preživljavanja bez događaja (EFS) u usporedbi s bolesnicima iz kontrolne kohorte (n=120), koji su primali standardnu kemoterapiju bez imatiniba (69,6% u odnosu na 31,6%).
English: In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56].
Croatian: U planiranoj analizi podskupine prema vrsti mutacije je omjer rizika za preživljenje bez recidiva bolesti kod 36-mjesečnog liječenja bolesnika s mutacijama na 11. eksonu bio 0,35 [95% CI: 0,22, 0,56].
English: Anaphylactic shock* Blood and lymphatic system disorders
Croatian: Poremećaji imunološkog sustava Poremećaji krvi i limfnog sustava
English: • Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Croatian: • Pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon neuspjeha terapije interferonom-alfa, ili u ubrzanoj fazi ili u blastičnoj krizi.
English: 3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study
Croatian: 3 Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
English: They are usually
Croatian: Manje često
English: Imatinib Teva B.V. may cause your body to retain water (severe fluid retention).
Croatian: Imatinib Teva B.V. može izazvati zadržavanje vode u tijelu (teška retencija
English: In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥30 mg/kg/day.
Croatian: U 2-godišnjoj studiji kancerogenosti u štakora primjena imatiniba od 15, 30 i 60 mg/kg/dan rezultirala je statistički značajnim smanjenjem dužine života mužjaka uz 60 mg/kg/dan i ženki uz
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at
Croatian: Kranijalna iradijacija (Samo blok br. 5) 12 Gy u 8 frakcija za sve bolesnike koji imaju CNS1 i CNS2 u trenutku
English: Imatinib Teva B.V. is a medicine containing an active substance called imatinib.
Croatian: Imatinib Teva B.V. je lijek koji sadrži djelatnu tvar zvanu imatinib.
English: In this study 147 patients were enrolled and randomised to receive either 400 mg or 600 mg orally once daily for up to 36 months.
Croatian: U to je ispitivanje uključeno i randomizirano 147 bolesnika kako bi na dan primali bilo 400 mg bilo 600 mg peroralno tijekom razdoblja do 36 mjeseci.
English: (1 h) day 1;
Croatian: i.v.(1 h) dan 1;
English: At the time of analysis, the treatment duration was a median of 47
Croatian: U vrijeme analize, medijan trajanja liječenja bio je
English: (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Croatian: Postoji ograničeno iskustvo kod djece s Ph pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, GIST-omi HES/KEL-om.
English: What Imatinib Teva B.V. is and what it is used for
Croatian: Što je Imatinib Teva B.V. i za što se koristi
English: The effect of prior gastrointestinal surgery on drug absorption has not been investigated.
Croatian: Učinak prethodnog gastrointestinalnog kirurškog zahvata na apsorpciju lijeka nije
English: All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to
Croatian: Svih 65 bolesnika s pozitivnom FIP1L1-PDGFRα fuzijskom kinazom postiglo je CHR koji se održao mjesecima (raspon od 1+ do 44+ mjeseci, izostavljeno u trenutku izvještavanja).
English: Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolobenzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e.
Croatian: Imatinib može povećati koncentraciju drugih lijekova u plazmi koje metabolizira CYP3A4 (npr. triazolo-benzodiazepini, dihidropiridinski blokatori kalcijevih kanala, određeni inhibitori HMG-CoA reduktaze odnosno statini, itd.).
English: If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Croatian: Ako se tijekom primjene imatinibom razvije teška nehematološka nuspojava, liječenje se mora prekinuti sve do oporavka od nuspojave.
English: For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg film-coated tablet is
Croatian: Za doze različite od doza od 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta od 100 mg.
English: The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm.
Croatian: Duljina kapsule je od 19,1 mm do 19,7 mm, a širina iznosi 6,91 mm Imatinib Teva B.V.
English: The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes.
Croatian: GIST-a nije imala podatke koji bi potvrdili c-Kit ili PDGFR mutacije koje su možda dovele do miješanih kliničkih ishoda.
English: The diameter of the film-coated tablet is
Croatian: Promjer filmom obložene tablete je približno
English: 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache,
Croatian: 1200 mg do 1600 mg (trajanje je variralo između jednog i 10 dana): mučnina, povraćanje, proljev, osip, eritem, edem, oticanje, umor, mišićni spazam, trombocitopenija, pancitopenija, bol u trbuhu,
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Croatian: Analizom je potvrđeno da je izloženost imatinibu u pedijatrijskih bolesnika koji su primali 260 mg/m jedanput na dan (najviše 400 mg jedanput na dan) ili 340 mg/m2 jedanput na dan (najviše 600 mg jedanput na dan) bila slična onoj u odraslih bolesnika koji su primali imatinib 400 mg ili 600 mg jedanput na dan.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib until
Croatian: Ako citopenija potraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve
English: Frequency categories are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti se definiraju kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
English: In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Croatian: Izloženost imatinibu u plazmi je izgleda viša kod bolesnika s oštećenom funkcijom bubrega, vjerojatno zbog povišene razine alfa-kiselog glikoproteina (AGP) u plazmi, proteina koji veže imatinib, u tih bolesnika.
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract
Croatian: Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis, infekcija gornjih dišnih puteva, gripa, infekcija mokraćnog sustava,
English: CML (CML-AP and CML-BC) than in patients with chronic CML.
Croatian: KML-om (KML-ubrzana faza i KML-blastična kriza), nego u bolesnika s kroničnim KML-om.
English: 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in
Croatian: 10 Mišićno-koštana bol i vezane nuspojave su češće uočeni u bolesnika s KML-om, nego u
English: During treatment with Imatinib Teva B.V., tell your doctor straight away if you put on weight very quickly.
Croatian: Tijekom liječenja Imatinibom Teva B.V. odmah obavijestite svog liječnika ako vrlo brzo dobivate na težini.
English: Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Croatian: 260 mg/m2/dan (n=5), 340 mg/m2/dan (n=9), 440 mg/m2/dan (n=7), te 570 mg/m2/dan (n=5).
English: Imatinib Teva B.V. is a treatment for: - Chronic myeloid leukaemia (CML).
Croatian: Imatinib Teva B.V. se koristi za liječenje: - Kronične mijeloične leukemije (KML).
English: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST.
Croatian: Učinkovitost imatiniba u odraslih i pedijatrijskih bolesnika temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez napredovanja bolesti u bolesnika sa KML-om, na hematološkim i citogenetskim stopama odgovora u bolesnika s Ph+ ALL i MDS/MPB-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om, te na objektivnim stopama odgovora u odraslih bolesnika s DFSP-om.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
English: 100 vs. 98.7 100 vs. 95.5 0.59 (0.17; 2.10) 100 vs. 94.8 97.8 vs. 89.5 44.8 21/140 vs. 51/127 0.29 (0.18; 0.49) 94.8 vs. 64.0 80.7 vs. 46.6 N.E.
Croatian: 100 vs. 98,7 100 vs. 95,5 0,59 (0,17; 2,10) 100 vs. 94,8 97.8 vs. 89,5 44,8 21/140 vs. 51/127 0,29 (0,18; 0,49) 94.8 vs. 64,0 80.7 vs. 46,6 NP
English: • Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Croatian: • Kombinacija teškog proširenog osipa, mučnine, vrućice, visoke razine određenih bijelih krvnih stanica ili žutila kože ili očiju (znakovi žutice) s nedostatkom zraka, bol/nelagoda u prsnom košu, jako smanjenim mokrenjem i žeđi itd. (znakovi alergijske reakcije povezane s liječenjem).
English: Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Croatian: Izgleda da prilagođavanje doze nije neophodno kada se imatinib istodobno primjenjuje sa supstratima CYP2D6, međutim, savjetuje se oprez kod supstrata
English: Description of selected adverse reactions Hepatitis B reactivation
Croatian: Ponovna aktivacija hepatitisa B
English: The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Croatian: Učinkovitost imatiniba temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez znakova progresije bolesti.
English: • 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.
Croatian: • Crvenilo i/ili oticanje dlanova ruku i tabana stopala koje može biti praćeno trncima i bolnim
English: If this applies to you, tell your doctor without taking Imatinib Teva B.V.
Croatian: Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Teva B.V..
English: • Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
Croatian: • Mučnina uz gubitak apetita, tamna boja mokraće, žutilo kože ili očiju (znakovi problema s
English: - The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium stearate.
Croatian: - Ostali sastojci su bezvodni kalcijev hidrogenfosfat, krospovidon i magnezijev stearat.