natgillin/translations-raw huggingface dataset:
Median time to treatment failure in responders was 122 weeks (95% C.I 106-147), while in the overall study population it was 84 weeks (95% C.I 71-109).
Medijan vremena do neuspjeha liječenja u bolesnika koji su odgovorili na terapiju bio je 122 tjedna (95% CI 106-147), odnosno 84 tjedana (95% CI 71-109) u ukupno ispitivanoj populaciji.
The doctor will tell you how many capsules of Glivec to give to your child.
Liječnik će Vam reći koliko kapsula Gliveca trebate dati djetetu.
An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with Glivec.
Proveden je opservacijski registar (ispitivanje L2401) da bi se prikupili podaci o dugoročnoj sigurnosti primjene i djelotvornosti u bolesnika s mijeloproliferativnim novotvorinama s PDGFR- β preraspodjelom, a koji su liječeni Glivecom.
Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Imatinib je mala molekula, inhibitor protein-tirozin kinaze, koja potentno inhibira aktivnost Bcr-Abl tirozin kinaze (TK), kao i nekoliko TK receptora: Kit, receptor za faktor matičnih stanica (SCF, engl. stem cell factor) kodiran c-Kit protoonkogenom, receptore za diskoidinsku domenu (DDR1 i DDR2, engl. discoidin domain receptors), receptor za faktor stimulacije kolonija (CSF-1R, engl. colony stimulating factor receptor) te alfa i beta receptore za faktor rasta koji potječe od trombocita (PDGFR-alfa i PDGFR-beta).
What Glivec contains - The active substance is imatinib mesilate.
Što Glivec sadrži - Djelatna tvar je imatinibmesilat.
They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.
Nalaze se u pakiranjima koja sadrže 24, 48, 96, 120 ili 180 kapsula, ali ona sva ne moraju biti dostupna u Vašoj zemlji.
Table 3 Response in adult CML studies
Tablica 3 Odgovor u ispitivanjima KML-a u odraslih
At one year the overall RFS was significantly better for Glivec (97.7%) vs. placebo (82.3%), (p<0.0001).
Nakon jedne godine ukupno preživljenje bez recidiva bolesti bilo je značajno bolje za Glivec (97,7%) u odnosu na placebo (82,3%), (p<0,0001).
Elimination Based on the recovery of compound(s) after an oral
Na temelju izlučivanja spoja(eva) nakon oralne,
• Use about 50 ml for each 100 mg tablet.
• Uzmite oko 50 ml za svaku tabletu od 100 mg.
20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets
20 filmom obloženih tableta 60 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta
Anaphylactic shock* Blood and lymphatic system disorders Very common:
Anafilaktički šok* Poremećaji krvi i limfnog sustava Vrlo često:
Packs containing 10, 30 or 90 film-coated tablets
Pakiranja sadrže 10, 30 ili 90 filmom obloženih tableta
A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day Glivec 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.
Drugo otvoreno multicentrično ispitivanje faze III (SSG XVIII/AIO) uspoređivalo je 12 mjeseci liječenja Glivecom 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.
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common:
Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)*, pseudoporfirija* Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često:
6-MP 60 mg/m oral, days 26-46
6-MP 60 mg/m peroralno, dani 26-46
9/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
9/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (59-64% i 44-63% za neutropeniju odnosno trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9% trombocitopenija).
In vitro Glivec inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Glivec in vitro inhibira aktivnost CYP2D6 izoenzima citokroma P450 u koncentracijama koje su slične onima što utječu na djelovanje CYP3A4.
Continuous daily exposure to Glivec early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without Glivec (69.6% vs. 31.6%, respectively).
Stalna svakodnevna izloženost Glivecu 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 Gliveca (69,6% u odnosu na 31,6%).
For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.
Za doze, osim 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) dostupna je tableta od 100 mg koja se može prepoloviti.
To conduct an observational registry collecting efficacy and safety data in newly diagnosed paediatric Ph+ Acute Lymphoblastic Leukaemia (ALL) patients treated with chemotherapy + imatinib ± HSCT.
Provesti registar promatranja prikupljanjem podataka o djelotvornosti i sigurnosti u novodijagnosticiranih pedijatrijskih Ph+ akutna limfoblastična leukemija (ALL) bolesnika liječenih kemoterapijom + imatinib ± HSCT.
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.
- Ako niste u stanju progutati kapsule, možete ih otvoriti i istresti prašak u čašu negazirane vode ili soka od jabuke.
Maximal plasma concentrations of imatinib in patients are 2-4 mol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible.
Maksimalne koncentracije imatiniba u plazmi bolesnika iznose 2-4 mol/l pa je prema tome moguća inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
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, decreased appetite.
1200 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, glavobolja, smanjeni apetit.
Patients concerned about their fertility on Glivec treatment should consult with their physician.
Bolesnici zabrinuti radi svoje plodnosti tijekom liječenja Glivecom moraju se posavjetovati sa svojim liječnikom.
Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Glivec and IFN arms, respectively.
Sedam godina nakon uključivanja posljednjeg bolesnika, medijan trajanja prve linije liječenja bio je 82 mjeseca u Glivec kraku, odnosno 8 mjeseci u INF kraku.
Use in adults Your doctor will tell you exactly how many capsules of Glivec to take.
Primjena u odraslih osoba Liječnik će Vam reći točno koliko kapsula Gliveca trebate uzeti.
• Use about 200 ml for each 400 mg tablet.
• Uzmite oko 200 ml za svaku tabletu od 400 mg.
Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with Glivec (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
U ispitivanju I2301 ukupno 93 djece, adolescenata i mladih odraslih osoba (u dobi od 1 do 22 godine) s Ph+ ALL bilo je uključeno u otvoreno, multicentrično, sekvencijsko kohortno, nerandomizirano ispitivanje faze III u kojem su primali Glivec (340 mg/m2/dan) u kombinaciji s intenzivnom kemoterapijom nakon indukcijskog liječenja.
Tumour haemorrhage/tumour necrosis* Immune system disorders Not known:
Tumorsko krvarenje/tumorska nekroza* Poremećaji imunološkog sustava Nepoznato:
This study included 7 patients with MDS/MPD who were treated with Glivec 400 mg daily.
Ovo je kliničko ispitivanje uključivalo 7 bolesnika s MDS/MPD-om koji su liječeni Glivecom 400 mg na dan.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC  1 x 10
Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu Gliveca sve dok ABN ne bude 1 x 10
A further 6 DFSP patients treated with Glivec were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
U 5 objavljenih prikaza slučajeva zabilježeno je dodatnih 6 bolesnika s DFSP-om liječenih Glivecom, s rasponom starosti od 18 mjeseci do 49 godina.
3, pulmonary oedema
3, plućni edem
Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Dok je otprilike 96% bolesnika s CCyR-om, odnosno 93% bolesnika s PCyR-om nakon 12 mjeseci bilo bez progresije u ubrzanu fazu/blastičnu krizu nakon 84 mjeseca, samo je 81% bolesnika bez MCyR nakon 12 mjeseci bilo bez progresije u uznapredovali KML nakon 84 mjeseca (p<0,001 ukupno, p=0,25 između CCyR-a i PCyR-a).
Glivec significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the Glivec group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - nonestimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Glivec je značajno produljio preživljenje bez recidiva bolesti, pri čemu je 75% bolesnika bilo bez recidiva nakon 38 mjeseci u Glivec skupini, u odnosu na 20 mjeseci u placebo skupini (95% CIs, [30nije moguće procijeniti], odnosno [14 - nije moguće procijeniti]); (omjer rizika = 0,398 [0,259-0,610], p<0,0001).
Glivec is also a treatment for adults for:
Glivec se kod odraslih osoba također koristi za liječenje:
Accelerated phase is defined by the presence of any of the following: blasts  15% but < 30% in blood or bone marrow, blasts plus promyelocytes  30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils  20%, platelets < 100 x 10
Ubrzana faza se definira prisutnošću bilo kojeg od sljedećih kriterija: blasti 15% ali <30% u krvi ili koštanoj srži, blasti plus promijelociti 30% u krvi ili koštanoj srži (što daje <30% blasta), bazofili u perifernoj krvi 20%, trombociti <100 x 10
Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Aritmija, fibrilacija atrija, srčani zastoj, infarkt miokarda, angina pektoris, perikardijalna efuzija
The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Bubrežni adenom/karcinom, papilom mokraćnog mjehura i uretre, adenokarcinomi tankog crijeva, adenomi paratireoidnih žlijezda, dobroćudni i zloćudni medularni tumori nadbubrežnih žlijezda i papilomi/karcinomi nežljezdanog dijela želuca zabilježeni su uz 60 mg/kg/dan, što odgovara otprilike 1,7, odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 1,2 puta dnevne izloženosti u djece (temeljeno na AUC) kod 340 mg/m2/dan.
Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Papilom/karcinom žlijezde prepucija/klitorisa su zabilježeni pri dozama od 30 mg/kg/dan na više, što odgovara otprilike 0,5, odnosno 0,3 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 0,4 puta dnevne izloženosti u djece (temeljeno na AUC) kod 340 mg/m2/dan.
Figure 1 Kaplan-Meier estimates for primary recurrence-free survival endpoint (ITT population)
Slika 1 Kaplan-Meierova procjena preživljenja bez recidiva bolesti kao primarnog ishoda (ITT populacija)
Intermediate 25.7 4/75 vs. 6/78
25,7 4/75 vs. 6/78
In addition, thirty-six (36) months of Glivec treatment significantly prolonged overall survival (OS) compared to 12 months of Glivec treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 8, Figure 2).
Osim toga, trideset i šest (36) mjeseci liječenja Glivecom značajno je produljilo ukupno preživljenje (OS) u usporedbi s 12 mjeseci liječenja Glivecom (omjer rizika = 0,45 [0,22, 0,89], p=0,0187) (Tablica 8, Slika 2).
The risk of recurrence was thus reduced by approximately 89% as compared with placebo (hazard ratio = 0.113
Rizik od recidiva bolesti je smanjen za otprilike 89% u usporedbi s placebom (omjer rizika = 0,113 [0,049-0,264]).
For doses of 400 mg and above (see dosage recommendation below) a 400 mg tablet (not divisible) is available.
Za doze od 400 mg i više (vidjeti niže navedenu preporuku doziranja) postoji tableta od 400 mg koja se ne može prepoloviti.
Packs containing 20, 60, 120 or 180 film-coated tablets
Pakiranja sadrže 20, 60, 120 ili 180 filmom obloženih tableta
Active substances that may have their plasma concentration altered by Glivec 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.
Djelatne tvari čije bi koncentracije u plazmi Glivec 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.
Daunorubicin 30 mg/m i.v., days 1-3, 15-16;
Daunorubicin 30 mg/m i.v., dani 1-3, 15-16;
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
10 Mišićno-koštana bol i srodni događaji su češće uočeni u bolesnika s KML-om, nego u GIST bolesnika.
Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Novodijagnosticirani Ph+ ALL: U kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib korišten samostalno izazvao je značajno višu stopu potpunog hematološkog odgovora nego kemoterapija (96,3% u odnosu na 50%; p=0,0001).
Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Nakon pronalaska antigena, imunohistokemijske pretrage su rutinski provedene s Kit protutijelom (A-4502, poliklonski antiserum kunića, 1:100; DAKO Corporation, Carpinteria, Kalifornija) prema analizi metodom kompleksa avidin-biotin-peroksidaze.
AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Ukupni bilirubin: = 1,5 GGN AST: >GGN (može biti normalan ili <GGN ako je ukupni bilirubin >GGN)
In adult and paediatric patients, the effectiveness of Glivec 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.
Učinkovitost Gliveca 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-om i MDS/MPD-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om, na objektivnim stopama odgovora u odraslih bolesnika s inoperabilnim i/ili metastazirajućim GIST-om i DFSP-om te na preživljenju bez recidiva bolesti kod adjuvantnog liječenja GIST-a.
9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC  1.5 x 10
9/l, mijelociti+metamijelociti <5% u krvi, u krvi nema blasta i promijelocita, bazofili <20%, nema ekstramedularne zahvaćenosti], a u studijama 0102 i 0109 [ABN ≥1,5 x 10
One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) za ispitivanje Gliveca u raznim populacijama bolesnika koji pate od bolesti opasnih po život povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
How to store Glivec
Kako čuvati Glivec
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%.
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%.
The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Glivec arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Procijenjena stopa bolesnika bez progresije u ubrzanu fazu ili blastičnu krizu nakon 84 mjeseca bila je značajno viša u Glivec kraku u usporedbi s IFN krakom (92,5% prema 85,1%, p<0,001).
In the Glivec arm, patients were treated with 400 mg daily.
U Glivec kraku, bolesnici su liječeni dozom od 400 mg na dan.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4).
U bolesnika u kojih je obavljena tireoidektomija i koji primaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, kada se Glivec istodobno primjenjuje (vidjeti dio 4.4).
Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Zbog toga se preporučuje oprezno postupati kada se Glivec primjenjuje s CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel i kvinidin).
Table 7 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Tablica 7 Sažetak analiza preživljenja bez recidiva bolesti u ispitivanju Z9001 prema NIH i AFIP klasifikacijama rizika
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of Glivec daily.
U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL-om je liječeno Glivecom od 100 mg do 1000 mg na dan.
Vincristine 1.3 mg/m i.v., days 1, 8, 15, 21;
Vinkristin 1,3 mg/m i.v., dani 1, 8, 15, 21;
Complete blood counts must be performed regularly during therapy with Glivec.
Tijekom terapije Glivecom mora se redovito kontrolirati kompletna krvna slika.
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Pedijatrijska ubrzana faza KML-a i blastična kriza (početna doza 340 mg/m
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Flatulencija, abdominalna distenzija, gastroezofagealni refluks, konstipacija, suhoća usta, gastritis
• 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).
• 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).
Palpitations, tachycardia, cardiac failure congestive
Palpitacije, tahikardija, kongestivno zatajenje srca
This inhibition has not been observed in vivo after the administration of Glivec 400 mg and paracetamol 1000 mg. Higher doses of Glivec and paracetamol have not been studied.
Ovakva inhibicija nije uočena in vivo nakon primjene Gliveca u dozi od 400 mg i paracetamola u dozi od 1000 mg.
5, pharyngolaryngeal pain, pharyngitis
Pleuralni izljev 5, faringolaringealna bol, faringitis
High
Visoka
Treatment of CML patients with Glivec has been associated with neutropenia or thrombocytopenia.
Liječenje Glivecom je kod bolesnika s KML-om povezano s neutropenijom ili trombocitopenijom.
Not applicable
nije primjenjivo
Very dark yellow to brownish-orange film-coated tablet, round with “NVR” on one side and “SA” and score on the other side.
Jako tamnožuta do smećkastonarančasta okrugla filmom obložena tableta, s oznakom „NVR“ na jednoj te oznakom „SA“ i urezom na drugoj strani.
The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
U kraku s 12-mjesečnim liječenjem umrlo je ukupno 25 bolesnika, a u kraku s 36-mjesečnim liječenjem 12.
Pharmacokinetics of Glivec
Farmakokinetika Gliveca
Prednisolone 60 mg/m 2/day oral
Prednizolon 60 mg/m 2/dan peroralno
Treatment duration: In clinical trials, treatment with Glivec was continued until disease progression.
Trajanje liječenja: u kliničkim ispitivanjima se liječenje Glivecom nastavljalo sve do progresije bolesti.
If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 260 mg/m 3.
2. Ako citopenija nije povezana s leukemijom, dozu Gliveca treba smanjiti na 260 mg/m
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Hipokalemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija, giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatremija
IDA 9 mg/m oral, days 1-28;
IDA 9 mg/m peroralno, dani 1-28;