FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should therefore be exercised when using high doses of Glivec and paracetamol concomitantly.
Croatian: Stoga je potreban oprez prilikom istodobne primjene visokih doza Gliveca i paracetamola.
English: This is because Glivec could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: To je potrebno jer Glivec može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
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 smanjenog metabolizma.
English: Major response at 24 months (%)
Croatian: Veliki odgovor nakon 24 mjeseca (%)
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Glivec.
Croatian: Funkciju jetre (transaminaze, bilirubin, alkalna fosfataza) treba redovito kontrolirati u bolesnika koji primaju Glivec.
English: When Glivec is co-administered with other medicinal products, there is a potential for drug interactions.
Croatian: Kada se Glivec primjenjuje istodobno s drugim lijekovima postoji mogućnost za interakcije lijekova.
English: Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC code: L01XE01
Croatian: Farmakoterapijska skupina: inhibitor protein-tirozin kinaze, ATK oznaka: L01XE01
English: All patients received imatinib and consolidation chemotherapy (see Table 4) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Croatian: Svi su bolesnici primili imatinib i konsolidacijsku kemoterapiju (vidjeti Tablicu 4) nakon indukcije, a razine bcr-abl transkripcije bile su identične u dva kraka nakon 8 tjedana.
English: They may increase or decrease the effect of Glivec, either leading to increased side effects or making Glivec less effective.
Croatian: Oni mogu povećati ili smanjiti učinak Gliveca bilo povećanjem nuspojava ili smanjenjem učinka Gliveca.
English: Chronic phase, Interferon failure: 532 adult patients were treated at a starting dose of 400 mg.
Croatian: Kronična faza, neuspjeh interferona: 532 odrasla bolesnika liječena su s početnom dozom od 400 mg.
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Croatian: Sigurnost i djelotvornost imatiniba u djece s MDS/MPD-om, DFSP-om, GIST-om i HES/KEL-om mlađe od 18 godina nisu ustanovljene u kliničkim ispitivanjima.
English: Experience with Glivec in this indication is very limited and is based on haematological and cytogenetic response rates.
Croatian: Iskustvo s Glivecom u ovoj indikaciji je vrlo ograničeno te se temelji na hematološkom i citogenetskom odgovoru.
English: Talk to your doctor before taking Glivec: - if you have or have ever had a liver, kidney or heart problem.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Glivec: - ako imate, ili ste ikada imali, problema s jetrom, bubrezima ili srcem.
English: Glivec administration to patients without the genetic translocation generally results in no improvement.
Croatian: Primjena Gliveca bez genetske translokacije obično ne rezultira poboljšanjem.
English: 24 hard capsules 48 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
Croatian: 24 tvrdih kapsula 48 tvrdih kapsula 96 tvrdih kapsula 120 tvrdih kapsula 180 tvrdih kapsula
English: Glivec will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Croatian: Glivec Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka krvi ili čvrstih tumora.
English: If you forget to take Glivec - If you forget a dose, take it as soon as you remember.
Croatian: - Ako ste zaboravili dozu, uzmite ju čim se sjetite.
English: Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Croatian: Ukupni bilirubin: >3-10 GGN AST: bilo koja vrijednost GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
English: Glivec inhibits the growth of these cells in a certain subtype of these diseases.
Croatian: Glivec inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.
English: Neoplasm benign, malignant and unspecified (including cysts and polyps) Rare:
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Rijetko:
English: Haematological response Complete haematological response (CHR) No evidence of leukaemia (NEL)
Croatian: Hematološki odgovor Potpuni hematološki odgovor (CHR) Nema dokaza leukemije (NEL)
English: Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Croatian: Primjena u pedijatriji: ne postoji iskustvo kod djece s KML-om mlađe od 2 godine i s Ph+ALL mlađe od 1 godine (vidjeti dio 5.1).
English: Your doctor will discuss with you the possible risks of taking Glivec during pregnancy.
Croatian: Vam objasniti moguće rizike od uzimanja Gliveca tijekom trudnoće.
English: The duration of Glivec therapy can vary with the treatment programme selected, but generally longer exposures to Glivec have yielded better results.
Croatian: Trajanje terapije Glivecom može se razlikovati s obzirom na odabrani program liječenja, no općenito se može reći da su se dužom izloženošću Glivecu dobivali bolji rezultati.
English: Major response at 12 months (%)
Croatian: Veliki odgovor nakon 12 mjeseci (%)
English: Resume treatment with Glivec at previous dose (i.e. before severe adverse reaction).
Croatian: 2. Ponovno uvesti liječenje Glivecom u prijašnjoj dozi (tj. prije teške nuspojave).
English: 12 months 24 months 36 months 48 months 60 months Survival 36 months 48 months 60 months
Croatian: 12 mjeseci 24 mjeseca 36 mjeseci 48 mjeseci 60 mjeseci
English: Blast crisis is defined as blasts  30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Croatian: Blastična se kriza definira kao blasti 30% u krvi ili koštanoj srži ili postojanje ekstramedularne bolesti osim hepatosplenomegalije.
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 µM).
Croatian: Imatinib nije ometao biotransformaciju 5-fluorouracila, ali je inhibirao metabolizam paklitaksela, što je bila posljedica kompetitivne inhibicije CYP2C8 (Ki = 34,7 µM).
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Glivec should not be resumed.
Croatian: Ako su anti-ADAMTS13-protutijela povišena istodobno sa sniženom ADAMTS13 aktivnosti, liječenje Glivecom se ne smije nastaviti.
English: This may be a sign of damage to blood vessels known as thrombotic microangiopathy
Croatian: To može biti znak oštećenja krvnih žila znan kao trombotična mikroangiopatija (TMA).
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: Većina pedijatrijskih bolesnika liječenih zbog GIST-a nije imala podatke koji bi potvrdili c-Kit ili PDGFR mutacije koje su možda dovele do miješanih kliničkih ishoda.
English: The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Croatian: Iskustvo s Glivecom u bolesnika s MDS/MPD-om povezanim s preraspodjelom gena za PDGFR je vrlo ograničeno (vidjeti dio 5.1).
English: They have “NVR” on one side and “SA” and a score line on the other side.
Croatian: Imaju oznaku „NVR“ na jednoj strani te oznaku „SA“ i urez na drugoj strani.
English: The median duration of second-line treatment with Glivec was 64 months.
Croatian: Medijan trajanja druge linije liječenja za Glivec bio je 64 mjeseca.
English: For patients with reduction in Bcr-Abl transcripts of at least 3 logarithms at 12 months, the probability of remaining free from progression to accelerated phase/blast crisis was 99% at 84 months.
Croatian: Za bolesnike sa smanjenjem BcrAbl transkripcija za najmanje 3 logaritma nakon 12 mjeseci, vjerojatnost zadržavanja stanja bez progresije u ubrzanu fazu/blastičnu krizu bila je 99% nakon 84 mjeseca.
English: Table 8 12-month and 36-month Glivec treatment (SSGXVIII/AIO Trial)
Croatian: Tablica 8 12-mjesečno i 36-mjesečno liječenje Glivecom (SSGXVIII/AIO ispitivanje)
English: Major response at 84 months (%) * p<0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after  4 weeks): WBC < 10 x 10
Croatian: Veliki odgovor nakon 84 mjeseca (%) * p<0,001, Fischerov egzaktni test ** postotci molekularnog odgovora se temelje na dostupnim uzorcima Kriteriji hematološkog odgovora (svi se odgovori moraju potvrditi nakon ≥4 tjedna): WBC <10 x 10
English: 21 patients were treated with Glivec 400 mg daily, while the other 3 patients received lower doses.
Croatian: 21 bolesnik je liječen Glivecom 400 mg na dan, dok su preostala 3 bolesnika primala niže doze.
English: Glivec inhibits the growth of these cells.
Croatian: Glivec inhibira rast ovih stanica.
English: The 23 patients enrolled in this registry received Glivec at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Croatian: 23 bolesnika uključena u ovaj registar primala su Glivec s medijanom dnevne doze od 264 mg (raspon: 100 do 400 mg) i medijanom vremena trajanja od 7,2 godine (raspon od 0,1 do 12,7 godina).
English: Cytogenetic response Major response n (%) [95% CI]
Croatian: Citogenetski odgovor Veliki odgovor n (%) [95% CI]
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Croatian: Ileus/intestinalna opstrukcija*, gastrointestinalna perforacija*, divertikulitis*, gastrična antralna vaskularna ektazija (GAVE)*
English: Glivec is a medicine containing an active substance called imatinib.
Croatian: Glivec je lijek koji sadrži djelatnu tvar zvanu imatinib.
English: The pharmacokinetics of Glivec have been evaluated over a dosage range of 25 to 1,000 mg.
Croatian: Farmakokinetika Gliveca ocijenjena je na rasponu doziranja od 25 do 1000 mg.
English: The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) Glivec daily.
Croatian: Odrasli bolesnici navedeni u objavljenoj literaturi su liječeni ili s 400 mg (4 slučaja) ili s 800 mg (1 slučaj) Gliveca na dan.
English: - Patients who are concerned about their fertility while taking Glivec are advised to consult with their doctor.
Croatian: - Bolesnicima koji su zabrinuti za svoju plodnost tijekom uzimanja Gliveca se preporučuje da se posavjetuju sa svojim liječnikom.
English: In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Croatian: U Ph+ ALL bolesnika postoji kliničko iskustvo istodobne primjene Gliveca s kemoterapijom (vidjeti dio 5.1), no lijek-lijek interakcije između imatiniba i režima kemoterapije nisu dobro karakterizirane.
English: Using this approach, the estimated cumulative response rates for first-line treatment with Glivec improved from 12 months of therapy to 84 months of therapy as follows: CHR from 96.4% to 98.4% and CCyR from 69.5% to 87.2%, respectively.
Croatian: Korištenjem tog pristupa, procijenjene kumulativne stope odgovora za prvu liniju liječenja Glivecom su se poboljšale od 12 mjeseci do 84 mjeseca terapije kako slijedi: CHR od 96,4% do 98,4% i CCyR od 69,5% do 87,2%.
English: If you are being treated for DFSP:
Croatian: Ako se liječite zbog DFSP-a:
English: Overall hazard ratio (95%CI)*
Croatian: Ukupni omjer rizika (95%CI)*
English: Hepatitis B reactivation*
Croatian: Ponovna aktivacija hepatitisa B*
English: Posology for GIST
Croatian: Doziranje za GIST
English: Patients were treated with Glivec 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Croatian: Bolesnici su liječeni s 340 mg/m2/dan Gliveca, bez prekida u odsutnosti toksičnosti vezane uz dozu.
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Glivec, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13-antibody determination, should be completed.
Croatian: Ako se laboratorijski ili klinički nalaz povezan s TMA-om javi u bolesnika koji prima Glivec, liječenje je potrebno prekinuti i provesti temeljito istraživanje TMA, uključujući ADAMTS13 aktivnost i određivanje antiADAMTS13-protutijela.
English: In vitro, Glivec inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Croatian: In vitro, Glivec inhibira paracetamol O-glukuronidaciju s Ki vrijednosti od 58,5 mikromol/l.
English: In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of Glivec was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
Croatian: U dvije kliničke studije (studija B2222 i intergrupna studija S0033) dnevna doza Gliveca je povećana do 800 mg u bolesnika kod kojih je došlo do progresije pri nižim dnevnim dozama od 400 mg ili 600 mg.
English: Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline.
Croatian: Kriteriji velikog molekularnog odgovora: u perifernoj krvi, sniženje ≥3 logaritma u količini BcrAbl transkripcija (mjereno kvantitativnom real-time PCR metodom pomoću reverzne transkriptaze) u odnosu na standardiziranu osnovnu vrijednost.
English: Glivec treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Croatian: Liječenje Glivecom izazvalo je brzi odgovor u novodijagnosticiranih pedijatrijskih KML bolesnika sa CHR-om od 78% nakon 8 tjedana terapije.
English: Treatment schedule: On the basis of the existing data, Glivec has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL.
Croatian: Plan liječenja: na temelju postojećih podataka, Glivec se pokazao učinkovitim i sigurnim u dozi od 600 mg/ dan u kombinaciji s kemoterapijom u indukcijskoj fazi te u konsolidacijskoj fazi i fazi održavanja kemoterapije (vidjeti dio 5.1) u odraslih bolesnika s novodijagnosticiranim Ph+ ALL-om.
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Glivec (see section 4.8).
Croatian: Inhibitori BCR-ABL tirozin kinaze (TKI-evi) povezani su s trombotičnom mikroangiopatijom (TMA), uključujući izvješća o pojedinačnom slučaju za Glivec (vidjeti dio 4.8).
English: If any of these apply to you, tell your doctor before taking Glivec.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Gliveca.
English: The effect of Glivec treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported Glivec data with the primary data from another Phase III study using IFN+Ara-C (n=325) in an identical regimen.
Croatian: Učinak liječenja Glivecom na preživljenje u kroničnoj fazi novodijagnosticiranog KML-a je dodatno ispitivan u retrospektivnoj analizi gore navedenih Glivec podataka uz primarne podatke iz drugog ispitivanja faze III u kojem je primjenjivan INF+Ara-C (n=325) u identičnom režimu.
English: Studies on patients receiving Glivec and its effect on fertility and gametogenesis have not been performed.
Croatian: Nisu provedena ispitivanja na bolesnicima koji primaju Glivec o njegovom učinku na plodnost i gametogenezu.
English: This clinical effect was associated with a higher reduction in bcrabl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Croatian: Ovaj klinički učinak povezan je s većim smanjenjem u bcr-abl transkripciji u bolesnika liječenih imatinibom, nego u kraku koji je primao kemoterapiju, nakon 2 tjedna terapije (p=0,02).
English: From the safety data available, escalating the dose to 800 mg daily in patients progressing at lower doses of 400 mg or 600 mg daily does not seem to affect the safety profile of Glivec.
Croatian: Prema dostupnim podacima o sigurnosti primjene, izgleda da povećanje doze na 800 mg na dan, u bolesnika kod kojih je došlo do progresije pri nižim dozama od 400 mg ili 600 mg na dan, ne utječe na sigurnosni profil Gliveca.
English: If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Croatian: Ako je povećanje bilirubina >3 x institucionalne gornje granice normale (IGGN), ili jetrenih transaminaza >5 x IGGN vrijednosti, primjenu Gliveca treba ukinuti sve dok se razine bilirubina ne vrate na vrijednost <1,5 x IGGN vrijednosti, a razine transaminaze na vrijednost <2,5 x IGGN vrijednosti.
English: In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Croatian: U bolesnika s GIST-om (studija B2222), zapaženo je 6,8% ALT (alanin-aminotransferaza) povišenja 3. ili 4. stupnja, kao i 4,8% AST (aspartataminotransferaza) povišenja 3. ili 4. stupnja.
English: The effect of Glivec on the outcome of bone marrow transplantation has not been determined.
Croatian: Učinak Gliveca na ishod transplantacije koštane srži nije utvrđen.
English: • the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Croatian: • adjuvantno liječenje odraslih bolesnika s visokim rizikom od recidiva bolesti nakon resekcije Kit (CD117)-pozitivnog GIST-a.
English: In this retrospective analysis, the superiority of Glivec over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) Glivec patients and 63 (19.4%) IFN+Ara-C patients had died.
Croatian: U toj retrospektivnoj analizi pokazana je superiornost Gliveca nad INF+Ara-C-om u ukupnom preživljenju (p<0,001); unutar 42 mjeseca, umrlo je 47 (8,5%) bolesnika na Glivecu i 63 (19,4%) bolesnika na INF+Ara-C-u.
English: Glivec is a treatment for adults and children for:
Croatian: Glivec se kod odraslih osoba i djece koristi za liječenje:
English: With 7 years follow-up, there were 93 (16.8%) progression events in the Glivec arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Croatian: Nakon 7 godina praćenja, u Glivec kraku bilo je 93 (16,8%) događaja progresije: 37 (6,7%) je uključivalo progresiju u ubrzanu fazu/blastičnu krizu, 31 (5,6%) gubitak MCyR-a, 15 (2,7%) gubitak CHR-a ili povećanje WBC-a i 10 (1,8%) smrtnih slučajeva nevezanih uz KML.
English: However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of Glivec.
Croatian: No, ti su edemi rijetko bili teški te se mogu liječiti diureticima, drugim suportivnim mjerama, ili smanjenjem doze Gliveca.
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Glivec and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Croatian: Nakon 84 mjeseca, procijenjeno ukupno preživljenje iznosi 86,4% (83, 90) u odnosu na 83,3% (80, 87) u randomiziranoj Glivec, odnosno INF+Ara-C skupini (p=0,073, log-rang test).
English: Metabolism of Glivec is mainly hepatic, and only 13% of excretion is through the kidneys.
Croatian: Gliveca odvija se uglavnom preko jetre, dok se samo 13% izlučuje preko bubrega.
English: How much Glivec to take
Croatian: Koliko Gliveca uzeti
English: C-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: • the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Croatian: • liječenje odraslih bolesnika s inoperabilnim dermatofibrosarkomom protuberans (DFSP) i odraslih bolesnika s rekurentnim i/ili metastazirajućim DFSP-om koji nisu podobni za kirurški zahvat.
English: In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m
Croatian: K tome, mortalitet je uočen u juvenilnih životinja (oko faze odbijanja) pri izloženosti koja je iznosila otprilike 2 puta prosječne izloženosti u djece pri najvišoj preporučenoj dozi od 340 mg/m
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Croatian: Limfatična blastična kriza: U ispitivanjima faze I uključen je ograničeni broj bolesnika (n=10).
English: Probability of recurrence-free survival
Croatian: Vjerojatnost preživljenja bez recidiva
English: These reactions can usually be managed by withholding Glivec temporarily and with diuretics and other appropriate supportive care measures.
Croatian: Te se reakcije obično mogu liječiti tako da se Glivec privremeno prestane davati te da se primijene diuretici i druge odgovarajuće suportivne mjere.
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of Glivec resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Croatian: Prethodno liječenje s višestrukim dozama rifampicina od 600 mg, nakon čega je slijedila jednokratna doza Gliveca od 400 mg, rezultiralo je smanjenjem Cmax i AUC(0-∞) za najmanje 54% odnosno 74% bez liječenja rifampicinom.
English: Hazard ratio 0.46 (95% Cl, 0.32-0.65)
Croatian: Omjer rizika 0,46 (95% Cl, 0,32-0,65)
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received Glivec at doses from 75 mg to 800 mg daily.
Croatian: Dodatnih 162 bolesnika s HES/KEL-om, zabilježenih u 35 objavljenih prikaza slučajeva i serija slučajeva, primalo je Glivec u dozama od 75 mg do 800 mg na dan.
English: Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking Glivec.
Croatian: Pojava teške retencije tekućine (pleuralni izljev, edem, plućni edem, ascites, površinski edem) zabilježena je u približno 2,5% novodijagnosticiranih KML bolesnika koji su uzimali Glivec.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glivec in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Croatian: Europska Agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Glivec u svim podskupinama pedijatrijske populacije s kroničnom mijeloičnom leukemijom s pozitivnim Philadelphia kromosomom (bcr-abl translokacija) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: They are supplied in packs containing 10, 30 or 90 tablets, but these may not all be available in your country.
Croatian: Nalaze se u pakiranjima koja sadrže 10, 30 ili 90 tableta, ali ona sva ne moraju biti dostupna u Vašoj zemlji.