natgillin/translations-raw huggingface dataset:
BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Glivec (see section 4.8).
Inhibitori BCR-ABL tirozin kinaze (TKI-evi) povezani su s trombotičnom mikroangiopatijom (TMA), uključujući izvješća o pojedinačnom slučaju za Glivec (vidjeti dio 4.8).
If any of these apply to you, tell your doctor before taking Glivec.
Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Gliveca.
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.
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.
Studies on patients receiving Glivec and its effect on fertility and gametogenesis have not been performed.
Nisu provedena ispitivanja na bolesnicima koji primaju Glivec o njegovom učinku na plodnost i gametogenezu.
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).
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).
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.
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.
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.
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.
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.
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.
The effect of Glivec on the outcome of bone marrow transplantation has not been determined.
Učinak Gliveca na ishod transplantacije koštane srži nije utvrđen.
• the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
• adjuvantno liječenje odraslih bolesnika s visokim rizikom od recidiva bolesti nakon resekcije Kit (CD117)-pozitivnog GIST-a.
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.
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.
Glivec is a treatment for adults and children for:
Glivec se kod odraslih osoba i djece koristi za liječenje:
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.
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.
However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of Glivec.
No, ti su edemi rijetko bili teški te se mogu liječiti diureticima, drugim suportivnim mjerama, ili smanjenjem doze Gliveca.
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).
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).
Metabolism of Glivec is mainly hepatic, and only 13% of excretion is through the kidneys.
Gliveca odvija se uglavnom preko jetre, dok se samo 13% izlučuje preko bubrega.
How much Glivec to take
Koliko Gliveca uzeti
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).
C-označene doze imatiniba, oko 81% doze izlučilo se u roku od 7 dana u stolici (68% doze) i mokraći (13% doze).
• 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.
• liječenje odraslih bolesnika s inoperabilnim dermatofibrosarkomom protuberans (DFSP) i odraslih bolesnika s rekurentnim i/ili metastazirajućim DFSP-om koji nisu podobni za kirurški zahvat.
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
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
Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Limfatična blastična kriza: U ispitivanjima faze I uključen je ograničeni broj bolesnika (n=10).
Probability of recurrence-free survival
Vjerojatnost preživljenja bez recidiva
These reactions can usually be managed by withholding Glivec temporarily and with diuretics and other appropriate supportive care measures.
Te se reakcije obično mogu liječiti tako da se Glivec privremeno prestane davati te da se primijene diuretici i druge odgovarajuće suportivne mjere.
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.
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.
Hazard ratio 0.46 (95% Cl, 0.32-0.65)
Omjer rizika 0,46 (95% Cl, 0,32-0,65)
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.
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.
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.
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.
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).
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).
They are supplied in packs containing 10, 30 or 90 tablets, but these may not all be available in your country.
Nalaze se u pakiranjima koja sadrže 10, 30 ili 90 tableta, ali ona sva ne moraju biti dostupna u Vašoj zemlji.
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Postoji ograničeno iskustvo kod djece s Ph-pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, GIST-om i HES/KEL-om.
Chronic phase, newly diagnosed: This phase III study in adult patients compared treatment with either single-agent Glivec or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Kronična faza, novodijagnosticirani: u ovom ispitivanju faze III. u odraslih bolesnika uspoređivalo se liječenje ili samo s jednim agensom - Glivecom ili s kombinacijom interferona-alfa (IFN) plus citarabina (Ara-C).
After resection of primary GIST, patients were randomised to one of the two arms: Glivec at 400 mg/day or matching placebo for one year.
Nakon resekcije primarnog GIST-a, bolesnici su randomizirani u jedan od dva kraka: Glivec 400 mg/dan ili odgovarajući placebo tijekom jedne godine.
Study 0110 37-month data Chronic phase, IFN failure (n=532)
Studija 0110 37-mjesečni podaci Kronična faza, neuspjeh IFN terapije (n=532)
Acute respiratory failure
Akutno zatajenje disanja
Glivec was administered intermittently in cohorts 1-5, with increasing duration and earlier start of Glivec from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of Glivec (longest duration in days with continuous daily Glivec dosing during the first chemotherapy treatment courses).
Glivec je povremeno primjenjivan u kohortama 1-5, uz progresivno produljenje i raniji početak primjene Gliveca od jedne do druge kohorte, pri čemu je kohorta 1 primala najmanji intenzitet, a kohorta 5 najveći intenzitet Gliveca (najdulje trajanje u danima kontinuiranog uzimanja dnevne doze Gliveca tijekom prvih ciklusa kemoterapije).
Posology for CML in children Dosing for children should be on the basis of body surface area (mg/m2).
U djece se doziranje treba temeljiti na veličini površine tijela (mg/m2).
Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Slični rezultati su uočeni u bolesnika s malignim gliomima koji su liječeni Glivecom dok su uzimali antiepileptičke lijekove koji induciraju enzime, poput karbamazepina, okskarbazepina i fenitoina.
Hazard ratio 0.45 (95% Cl, 0.22-0.89)
Omjer rizika 0,45 (95% Cl, 0,22-0,89)
Imatinib in combination with chemotherapy induction (see Table 4) 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).
Imatinib u kombinaciji s indukcijskom kemoterapijom (vidjeti Tablicu 4) rezultira postizanjem stope potpunog hematološkog odgovora od 93% (147 od 158 procijenjenih bolesnika) i stope velikog citogenetskog odgovora od 90% (19 od 21 procijenjenog bolesnika).
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m 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.
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/m 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.
Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1).
Trajanje liječenja: u jedinom kliničkom ispitivanju provedenom do sada, liječenje Glivecom je nastavljeno do progresije bolesti (vidjeti dio 5.1).
Pharmacokinetics in children
Farmakokinetika u djece
PVDC/alu blisters Packs containing 60, 120 or 180 film-coated tablets
PVDC/Al blisteri Pakiranja sadrže 60, 120 ili 180 filmom obloženih tableta
Glivec is indicated for the treatment of
Glivec je indiciran za liječenje
Patients had received a median of 14 months of prior IFN therapy at doses  25 x 10
Bolesnici su prethodno primali IFN terapiju u medijanu trajanja od 14 mjeseci u dozama ≥25 x 10
9/l, then resume treatment at 200 mg/m
9/l, nakon toga nastaviti liječenje u dozi od 200 mg/m
In vitro, imatinib inhibits proliferation and induces apoptosis in gastrointestinal stromal tumour (GIST) cells, which express an activating kit mutation.
In vitro, imatinib inhibira proliferaciju te inducira apoptozu u stanicama gastrointestinalnog stromalnog tumora (GIST) koje ispoljavaju aktivaciju kit mutacije.
Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Ara-C: citozin arabinozid; CP: ciklofosfamid; DEX: deksametazon; MTX: metotreksat; 6-MP: 6merkaptopurin; VM26: tenipozid; VCR: vinkristin; IDA: idarubicin; i.v.: intravenski
EU/1/01/198/009 10 tablets EU/1/01/198/010 30 tablets EU/1/01/198/013 90 tablets
EU/1/01/198/009 10 tableta EU/1/01/198/010 30 tableta EU/1/01/198/013 90 tableta
For adult patients with relapsed or refractory Ph+ALL Glivec monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Za odrasle bolesnike s recidivirajućim ili refraktornim Ph+ ALL-om, monoterapija Glivecom u dozi od 600 mg/dan je sigurna, učinkovita te se može davati do pojave progresije bolesti.
Glivec is also a treatment for children with CML.
Glivec se kod djece također koristi za liječenje KML-a.
Carriers of HBV who require treatment with Glivec should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Nositelje virusa HBV kojima je potrebno liječenje Glivecom potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
There were a total of 397 patients consented and randomised to the study (199 patients on 12-month arm and 198 patients on 36-month arm), median age was 61 years (range 22 to 84 years).
Ukupno 397 bolesnika je pristalo sudjelovati i biti randomizirano u ispitivanju (199 bolesnika u 12-mjesečni krak i 198 bolesnika u 36-mjesečni krak), pri čemu je medijan starosti bio 61 godina (raspon od 22 do 84 godina).
How to take Glivec
Kako uzimati Glivec
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement.
• odraslih bolesnika s uznapredovalim hipereozinofilnim sindromom (HES) i/ili kroničnom eozinofilnom leukemijom (KEL) s FIP1L1-PDGFR preraspodjelom.
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses  750 mg (phase I study).
Kod KML-a, citopenije su, osobito neutropenija i trombocitopenija, bile stalan nalaz u svim ispitivanjima, s naznakom da je učestalost veća uz visoke doze 750 mg (ispitivanje faze I).
EU/1/01/198/007 20 tablets (PVC/alu blisters) EU/1/01/198/008 60 tablets (PVC/alu blisters) EU/1/01/198/011 120 tablets (PVC/alu blisters) EU/1/01/198/012 180 tablets (PVC/alu blisters) EU/1/01/198/014 60 tablets (PVDC/alu blisters) EU/1/01/198/015 120 tablets (PVDC/alu blisters) EU/1/01/198/016 180 tablets (PVDC/alu blisters)
EU/1/01/198/007 20 tableta (PVC/Al blisteri) EU/1/01/198/008 60 tableta (PVC/Al blisteri) EU/1/01/198/011 120 tableta (PVC/Al blisteri) EU/1/01/198/012 180 tableta (PVC/Al blisteri) EU/1/01/198/014 60 tableta (PVDC/Al blisteri) EU/1/01/198/015 120 tableta (PVDC/Al blisteri) EU/1/01/198/016 180 tableta (PVDC/Al blisteri)
No. of events / No. of patients
Broj događaja / broj bolesnika
Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 10
Kronična faza KML-a se definira kada su ispunjeni svi navedeni kriteriji: blasti <15% u krvi i koštanoj srži, bazofili u perifernoj krvi <20%, trombociti >100 x 10
Stop Glivec until ANC  1.5 x 10
Ukinuti Glivec sve dok ABN ne bude 1,5 x 10
Complete response Partial response Stable disease Progressive disease Not evaluable Unknown
Potpuni odgovor Djelomični odgovor Stabilna bolest
• the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
• liječenje odraslih bolesnika s Kit (CD 117) pozitivnim inoperabilnim i/ili metastazirajućim malignim gastrointestinalnim stromalnim tumorima (GIST).
Confusional state Nervous system disorders Very common:
Konfuzno stanje Poremećaji živčanog sustava Vrlo često:
EU/1/01/198/002 24 capsules EU/1/01/198/003 48 capsules EU/1/01/198/004 96 capsules EU/1/01/198/005 120 capsules EU/1/01/198/006 180 capsules
EU/1/01/198/002 24 kapsula EU/1/01/198/003 48 kapsula EU/1/01/198/004 96 kapsula EU/1/01/198/005 120 kapsula EU/1/01/198/006 180 kapsula
Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)
Kronična faza KML-a, MDS/MPD-a i GIST-a (početna doza 400 mg) HES/KEL (doza od 400 mg)
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
Kada im je doza dana uz obrok s velikim sadržajem masti, brzina apsorpcije imatiniba se minimalno smanjila (11% smanjenje vrijednosti Cmax i produženje tmax za 1,5 h), uz malo smanjenje AUC vrijednosti (7,4%) u usporedbi kod stanja natašte.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 10
Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je učestalost neutropenije stupnja 3 i 4 (ABN <1,0 x 10
• Muscle cramps or joint, muscle or bone pain, during Glivec treatment or after you have stopped taking Glivec.
• grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Glivecom ili nakon prekida uzimanja Gliveca.
A total of 71 (12.8%) and 85 (15.4%) patients died in the Glivec and IFN+Ara-C groups, respectively.
Ukupno je umro 71 (12,8%) bolesnik iz Glivec skupine i 85 (15,4%) bolesnika iz INF+Ara-C skupine.
• Chest pain, irregular heart rhythm (signs of heart problems).
• bolovi u prsima, nepravilan srčani ritam (znakovi srčanih problema).
If a severe non-haematological adverse reaction develops with Glivec use, treatment must be withheld until the event has resolved.
Ako se tijekom primjene Gliveca razvije teška nehematološka nuspojava, liječenje se mora prekinuti sve dok se događaj ne razriješi.
• Do not use this medicine after the expiry date which is stated on the carton after EXP.
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza „Rok valjanosti“ ili na blisteru iza oznake „EXP“.
The dose of 340 mg/m daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Doza od 340 mg/m na dan preporučuju se za djecu s kroničnom fazom KML-a i s uznapredovalom fazom KML-a (ne smije se prekoračiti ukupna doza od 800 mg).
The doctor will tell you how many tablets of Glivec to give to your child.
Liječnik će Vam reći koliko tableta Gliveca trebate dati djetetu.
At the time of analysis, the treatment duration was a median of 47 months (24 days - 60 months).
U vrijeme analize, medijan trajanja liječenja bio je 47 mjeseci (24 dana - 60 mjeseci).
If you are being treated for HES/CEL:
Ako se liječite zbog HES/KEL-a:
These patients received Glivec for a median of 47 months (range 24 days - 60 months).
Ti su bolesnici primali Glivec za medijan od 47 mjeseci (raspon 24 dana - 60 mjeseci).
This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to Glivec.
Na to vrijeme-dodogađaja kao cilj ispitivanja je snažno utjecala visoka stopa prelazaka sa INF+Ara-C na Glivec.
BM = bone marrow, PB = peripheral blood Cytogenetic response criteria: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%) Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
KS = koštana srž, PK = periferna krv Kriteriji citogenetskog odgovora: Veliki odgovor je kombinacija potpunih i djelomičnih odgovora: potpuni (0% Ph+ metafaza), djelomični (1-35%) Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
9/l, mijelociti+metamijelociti <5% u krvi, nema blasta i promijelocita u krvi, bazofili < 20%, nema ekstramedularne zahvaćenosti Kriteriji citogenetskog odgovora: potpun (0% Ph+ metafaza), djelomičan (1-35%), manji (36-65%) ili minimalan (66-95%).
The estimated rate of progression-free survival at 84 months was 81.2% in the Glivec arm and 60.6% in the control arm (p<0.001).
Procijenjena stopa preživljenja bez progresije nakon 84 mjeseca bila je 81,2% u Glivec kraku i 60,6% u kontrolnom kraku (p<0,001%).
Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced, blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Tri velika, internacionalna, otvorena, nekontrolirana klinička ispitivanja faze II provedena su u bolesnika s KML-om s pozitivnim Philadelphia (Ph+) kromosomom, u uznapredovaloj, blastičnoj ili ubrzanoj fazi bolesti, s drugim Ph+ leukemijama ili u bolesnika s KML-om u kroničnoj fazi, ali u kojih nije uspjela prethodna terapija interferonom-alfa (IFN).
Use in adults Your doctor will tell you exactly how many tablets of Glivec to take.
Primjena u odraslih osoba Liječnik će Vam reći točno koliko tableta Gliveca trebate uzeti.
Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Glivec 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.).
Haematological response CHR rate n (%)
Hematološki odgovor CHR stopa n (%)
Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Glivec (see section 4.8).
Zbog moguće pojave sindroma lize tumora, prije početka terapije Glivecom preporučuje se korekcija klinički značajne dehidracije i liječenje visokih razina mokraćne kiseline (vidjeti dio 4.8).
There is very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Postoji vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, GIST-om ili HES/KEL-om.