natgillin/translations-raw huggingface dataset:
Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolobenzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e.
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.).
If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Ako se tijekom primjene imatinibom razvije teška nehematološka nuspojava, liječenje se mora prekinuti sve do oporavka od nuspojave.
For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg film-coated tablet is
Za doze različite od doza od 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta od 100 mg.
The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm.
Duljina kapsule je od 19,1 mm do 19,7 mm, a širina iznosi 6,91 mm Imatinib Teva B.V.
The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes.
GIST-a nije imala podatke koji bi potvrdili c-Kit ili PDGFR mutacije koje su možda dovele do miješanih kliničkih ishoda.
The diameter of the film-coated tablet is
Promjer filmom obložene tablete je približno
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,
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,
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.
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.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib until
Ako citopenija potraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve
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).
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
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.
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.
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract
Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis, infekcija gornjih dišnih puteva, gripa, infekcija mokraćnog sustava,
CML (CML-AP and CML-BC) than in patients with chronic CML.
KML-om (KML-ubrzana faza i KML-blastična kriza), nego u bolesnika s kroničnim KML-om.
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in
10 Mišićno-koštana bol i vezane nuspojave su češće uočeni u bolesnika s KML-om, nego u
During treatment with Imatinib Teva B.V., tell your doctor straight away if you put on weight very quickly.
Tijekom liječenja Imatinibom Teva B.V. odmah obavijestite svog liječnika ako vrlo brzo dobivate na težini.
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).
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).
Imatinib Teva B.V. is a treatment for: - Chronic myeloid leukaemia (CML).
Imatinib Teva B.V. se koristi za liječenje: - Kronične mijeloične leukemije (KML).
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.
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.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
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.
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
• 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).
• 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).
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.
Izgleda da prilagođavanje doze nije neophodno kada se imatinib istodobno primjenjuje sa supstratima CYP2D6, međutim, savjetuje se oprez kod supstrata
Description of selected adverse reactions Hepatitis B reactivation
Ponovna aktivacija hepatitisa B
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Učinkovitost imatiniba temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez znakova progresije bolesti.
• 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.
• Crvenilo i/ili oticanje dlanova ruku i tabana stopala koje može biti praćeno trncima i bolnim
If this applies to you, tell your doctor without taking Imatinib Teva B.V.
Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Teva B.V..
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
• Mučnina uz gubitak apetita, tamna boja mokraće, žutilo kože ili očiju (znakovi problema s
- The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium stearate.
- Ostali sastojci su bezvodni kalcijev hidrogenfosfat, krospovidon i magnezijev stearat.
- Imatinib Teva B.V. is not recommended during pregnancy unless clearly necessary as it may harm your baby.
- Imatinib Teva B.V. se ne smije upotrebljavati tijekom trudnoće, osim ako to nije neophodno.
- Myelodysplastic/myeloproliferative diseases (MDS/MPD).
- Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance.
Iz skupine potencijalnih lijekova za istodobnu primjenu (acetaminofen, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksiureja, norfloksacin, penicilin V) samo su eritromicin (IC50 50 µM) i flukonazol (IC50 118 µM) pokazali da inhibiraju metabolizam imatiniba što bi moglo biti klinički značajno.
Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Daunorubicin 45 mg/m2 i.v., dani 6-7, 13-14
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).
(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).
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
Daunorubicin 30 mg/m2 i.v., dani 1-3, 15-16;
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 imatinib (see
Zbog moguće pojave sindroma lize tumora, prije početka terapije imatinibom preporučuje se korekcija klinički značajne dehidracije i liječenje visokih razina mokraćne kiseline (vidjeti dio 4.8).
ULN = upper limit of normal for the institution
GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa, što je dovelo do transplantacije jetre ili smrtnog ishoda (vidjeti dio 4.4).
Thirty-six (36) months of imatinib treatment significantly prolonged RFS compared to 12 months of imatinib treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 7, Figure 1).
Trideset i šest (36) mjeseci liječenja imatinibom značajno je produljilo preživljenje bez recidiva bolesti u usporedbi s 12 mjeseci liječenja imatinibom (uz ukupan omjer rizika = 0,46 [0,32, 0,65], p<0,0001) (Tablica 7, Slika 1).
Start 6-MP the 1st day after cranial irradiation completion.)
6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1-og dana nakon završetka kranijalne iradijacije.)
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, koji 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).
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Najčešće zabilježene nuspojave (≥10%), u obje bolesti, koje su povezane s primjenom lijeka, bile su blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
Clinical studies in adjuvant GIST
Klinička ispitivanja kod adjuvantnog liječenja GIST-a
For doses of 400 mg and above (see dosage recommendation below) a 400 mg film-coated tablet is available.
Za doze od 400 mg i više (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed
Pleuralni izljev je češće zabilježen u bolesnika s GIST-om i u bolesnika s transformiranim
CHR: In study 0102 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease]
CHR: Studija 0102 [ABN ≥1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u KS <5% i nema ekstramedularne bolesti]
DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 i.v.
DEX 40 mg/dan na dane 1-4 i 11-14, izmjenjivano s MTX 1 g/m2 i.v. (24 h), dan 1,
• Itching.
• Osip.
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with
1 Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s
Imatinib Teva B.V. is indicated for
Imatinib Teva B.V. je indiciran za
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).
Abnormalne vrijednosti laboratorijskih testova U KML-u, 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).
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 dozu od 60 mg/kg/dan, što odgovara otprilike 1,7, odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan,
VCR 1 mg i.v., days 7, 14;
VCR 1 mg i.v., dani 7, 14;
Table 7 12-month and 36-month imatinib treatment (SSGXVIII/AIO Trial)
Tablica 7 12-mjesečno i 36-mjesečno liječenje imatinibom (SSGXVIII/AIO ispitivanje) Krak s 36-mjesečnim liječenjem
Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Imatinib je povremeno primjenjivan u kohortama 1-5, uz progresivno produljenje i raniji početak primjene imatiniba od jedne do druge kohorte, pri čemu je kohorta 1 primala najmanji intenzitet, a kohorta 5 najveći intenzitet
could cause hepatitis B to become active again, which can be fatal in some cases.
Imatinib Teva B.V. može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim slučajevima može rezultirati smrtnim ishodom.
After correcting for the BSA effect, other demographics such as age, body weight and body mass index did not have clinically significant effects on the exposure of imatinib.
Nakon korekcije s obzirom na učinak tjelesne površine, ostale demografske odrednice kao što su dob, tjelesna težina i indeks tjelesne mase,
Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Teška jetrena toksičnost zapažena je u pasa koji su liječeni 2 tjedna, uz povišene jetrene enzime, hepatocelularnu nekrozu, nekrozu žučnih vodova te
Active substances that may increase imatinib plasma concentrations:
Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti
The European Medicines Agency has waived the obligation to submit the results of studies with imatinib 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 imatiniba u svim podskupinama pedijatrijske populacije s Ph+ KML-om (vidjeti dio 4.2 za informacije o
Prednisolone 200 mg oral, 5 days per month for 13
Prednizolon 200 mg peroralno, 5 dana na mjesec
Table 1 Tabulated summary of adverse reactions
Tablica 1 Tablični sažetak nuspojava
Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates.
Klinička ispitivanja kod MDS/MPB-a Iskustvo s imatinibom u ovoj indikaciji je vrlo ograničeno te se temelji na hematološkom i citogenetskom odgovoru.
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).
Novodijagnosticirana Ph+ ALL: U kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib je kao monoterapija izazvao značajno višu stopu kompletnog hematološkog odgovora od kemoterapije (96,3% u odnosu na 50%; p=0,0001).
0.16 (0.03; 0.70) 97.9 vs. 90.8 97.9 vs. 73.3 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs. 41.5
100 vs. 100 97,8 vs. 100 0,16 (0,03; 0,70) 97,9 vs. 90,8 97,9 vs. 73,3 29,7 16/84 vs. 39/81 0,27 (0,15; 0,48) 98,7 vs. 56,1 79,9 vs. 41,5
Imatinib Teva B.V. inhibits the growth of these cells.
Imatinib Teva B.V. inhibira rast ovih stanica.
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%.
Recidivirajuća ili refraktorna Ph+ ALL: Primjena imatiniba kao monoterapije u bolesnika s recidivirajućom ili refraktornom Ph+ ALL, rezultirala je s odgovorom u 53 od 411 evaluirana bolesnika, sa stopom hematološkog odgovora od 30% (9% kompletni) i stopom većeg citogenetskog odgovora od 23%.
Clinical studies in unresectable and/or metastatic GIST One phase II, open-label, randomised, uncontrolled multinational study was conducted in patients with unresectable or metastatic malignant gastrointestinal stromal tumours (GIST).
Klinička ispitivanja kod inoperabilnog i/ili metastazirajućeg GIST-a Kod bolesnika s inoperabilnim ili metastazirajućim malignim gastrointestinalnim stromalnim tumorima (GIST) provedeno je jedno otvoreno, randomizirano, nekontrolirano, multinacionalno ispitivanje faze II.
The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the
Razina kod koje se ne uočava učinak (NOEL-no observed effect) i za roditeljske ženke i za F1 generaciju bila je 15 mg/kg/dan (jedna četvrtina maksimalne doze
(starting dose 340 mg/m2)
(početna doza 600 mg)
DEX 10 mg/m2 oral, days 6-7, 13-16;
DEX 10 mg/m2 peroralno, dani 6-7, 13-16;
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).
(95% CI 106-147), odnosno 84 tjedana (95% CI 71-109) u ukupno ispitivanoj populaciji.
4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
4 Crvenilo uz osjećaj vrućine je bilo najčešće u bolesnika s GIST-om, a krvarenje (hematomi, hemoragija) je bilo najčešće u bolesnika s GIST-om i s transformiranim KML-om (ubrzana faza
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Primarna varijabla djelotvornosti bila je stopa hematološkog odgovora, koja je zabilježena ili kao kompletni hematološki odgovor, stanje bez znakova leukemije ili kao vraćanje u kroničnu fazu KMLa, uz primjenu istih kriterija kao i kod ispitivanja u ubrzanoj fazi.
Resume treatment with imatinib at 600 mg. 3.
Nastaviti imatinib u dozi od 600 mg.
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Treatment duration: In clinical trials in GIST patients, treatment with imatinib was continued until disease progression.
Trajanje liječenja: u kliničkim ispitivanjima na bolesnicima s GIST-om, liječenje imatinibom nastavljeno je sve do progresije bolesti.
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 109/l) and thrombocytopenias (platelet count < 50 x 109/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).
stupnja (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/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).
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
MESNA (360 mg/m2/doza svaka 3 sata x 8 doza/dan, i.v.): dani 1-5 G-CSF (5 μg/kg, s.c.): dani 6-15 ili do porasta ANC >1500 nakon i.t. metotreksat (prilagođeno dobi): SAMO dan 1 Trostruka i.t. terapija (prilagođena dobi): dan 8, 15
There is very limited experience in children with MDS/MPD, DFSP, GIST
Postoji vrlo ograničeno iskustvo kod djece s MDS/MPBom, DFSP-om, GIST-om i HES/KEL-om.
VCR 2 mg i.v., days 6, 13, 20;
VCR 2 mg i.v., dani 6, 13, 20;
Patients concerned about their fertility on imatinib treatment should consult with their physician.
Bolesnici koji se liječe imatinibom, a zabrinuti su radi svoje plodnosti, moraju se posavjetovati sa svojim liječnikom.
• Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of
Imatinib Teva B.V. je indiciran za liječenje • Pedijatrijskih bolesnika s novodijagnosticiranom kroničnom mijeloičnom leukemijom (KML) s pozitivnim Philadelphia (Ph+) kromosomom (bcr-abl), u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja.
Musculoskeletal and connective tissue disorders Muscle spasm and cramps, musculoskeletal pain including myalgia9,
Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju9, artralgiju,
Liver function tests
Oštećenje funkcije organa
Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Prednizon 60 mg/m2 peroralno, dani 1-7, 15-21; IDA 9 mg/m2 peroralno, dani 1-28;