natgillin/translations-raw huggingface dataset:
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 imatinib.
Pojava teške retencije tekućine (pleuralni izljev, edem, plućni edem, ascites, površinski edem) zabilježena je u približno 2,5 % novodijagnosticiranih KML bolesnika koji su uzimali imatinib.
ANC < 0.5 x 10
ABN <0,5 x 10
Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Doze od 400 mg ili 600 mg treba primijeniti jednom na dan, dok se dnevna doza od 800 mg treba primijeniti kao 400 mg dvaput na dan, ujutro i navečer.
In eleven patients PDGFR gene rearrangements were detected, 9 of them achieved a CHR and 1 PHR.
U jedanaest bolesnika otkrivene su preraspodjele PDGFR gena, od kojih je 9 postiglo CHR, a 1 PHR.
In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2).
U bolesnika s poremećajem funkcije jetre (blagi, umjereni ili teški), potrebno je pažljivo pratiti perifernu krvnu sliku i jetrene enzime (vidjeti dijelove 4.2, 4.8 i 5.2).
There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib.
Prijavljeni su slučajevi zastoja u rastu koji su se pojavili kod djece i preadolescenata koji su primali imatinib.
Maintenance (8-week cycles) Cycles 6-12
Održavanje (8-tjedni ciklusi) Ciklusi 6-12
Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Mijelodisplastične/mijeloproliferativne bolesti s preraspodjelom PDGFR gena mogu biti povezane s visokim razinama eozinofila.
Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
Imatinib nije smatran genotoksičnim kada je ispitivan u in vitro pokusu na bakterijskim stanicama (Ames test), u in vitro pokusu na stanicama sisavaca (limfom miša) te u in vivo testu na mikronukleusu štakora.
• The active substance is imatinib (as mesilate).
• Djelatna tvar je imatinib (u obliku imatinibmesilata).
There is limited information on imatinib distribution on human milk.
Postoje ograničene informacije o distribuciji imatiniba u majčino mlijeko.
If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 5.2).
Ako se podnosi, doza se može povećati u nedostatku djelotvornosti (vidjeti dijelove 4.4 i 5.2).
What you need to know before you take Imatinib medac
Što morate znati prije nego počnete uzimati Imatinib medac
The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Vezanje N-demetiliranog metabolita na proteine plazme slično je onom roditeljske tvari.
Colitis, ileus, inflammatory bowel disease
Kolitis, ileus, upalna bolest crijeva
Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Pokazalo se da je imatinib in vitro kompetitivni inhibitor supstrata markera za CYP2C9, CYP2D6 i CYP3A4/5.
Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93 % (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90 % (19 out of 21 evaluable patients).
Imatinib u kombinaciji s indukcijskom kemoterapijom (vidjeti tablicu 3) 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).
Imatinib is a protein kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Imatinib je inhibitor protein kinaze koji snažno inhibira Bcr-Abl tirozin kinazu na in vitro, staničnom te in vivo nivou.
There was high between-patient variability in plasma imatinib AUC levels after an oral dose.
Između bolesnika postojala je velika varijabilnost u AUC razinama imatiniba u plazmi nakon jedne peroralne doze.
Patients should be monitored closely following dose escalation given the potential for an increased incidence of adverse reactions at higher dosages.
Nakon povećanja doze bolesnike treba pozorno pratiti, jer uz više doze postoji mogućnost za povećanu incidenciju nuspojava.
Imatinib adverse events, i.e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8).
Nuspojave imatiniba, npr. hepatotoksičnost, mijelosupresija ili drugo, mogu se pojačati te je zabilježeno da istodobna primjena s L-asparaginazom može biti povezana s povećanom hepatotoksičnošću (vidjeti dio 4.8).
Induction therapy (de novo Ph+ ALL)
Indukcijska terapija (de novo Ph+ ALL)
• Myelodysplastic/myeloproliferative diseases (MDS/MPD).
• Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
1800 mg do 3200 mg (najviše 3200 mg na dan tijekom 6 dana): slabost, mialgija, povišenje vrijednosti kreatinin fosfokinaze, povišenje vrijednosti bilirubina, bol u trbuhu.
However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML.
Međutim, pojava ovih citopenija ovisi o stadiju liječene bolesti, a one su češće u bolesnika s ubrzanom fazom KML-a ili blastičnom krizom, u odnosu na bolesnike s kroničnom fazom KML-a.
This Ki value is far higher than the expected plasma levels of imatinib in patients, consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib.
Ta Ki vrijednost je daleko viša nego što su očekivane razine imatiniba u plazmi bolesnika, pa se prema tome ne očekuje nikakva interakcija nakon istodobne primjene bilo 5-fluorouracila bilo paklitaksela i imatiniba.
In the study in patients with unresectable and/or metastatic GIST, 7 (5 %) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om, u 7 (5 %) bolesnika nastupilo je GI krvarenje CTC stupnja 3/4 (3 bolesnika), intratumorsko krvarenje (3 bolesnika) ili oboje (1 bolesnik).
The dose of 340 mg/m daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Doza od 340 mg/m na dan preporučuje se za djecu s Ph+ ALL (ne smije se prekoračiti ukupna doza od 600 mg).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in theagreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
In patients with hypereosinophilic syndrome (HES) with occult infiltration of HES cells within the myocardium, isolated cases of cardiogenic shock/left ventricular dysfunction have been associated with HES cell degranulation upon the initiation of imatinib therapy.
U bolesnika s hipereozinofilnim sindromom (HES) s okultnom infiltracijom HES stanica unutar miokarda, izolirani slučajevi kardiogenog šoka/disfunkcije lijeve klijetke bili su povezani s degranulacijom HES stanica po uvođenju terapije imatinibom.
• adult and paediatric patients with Ph+ CML in blast crisis.
• odraslih i pedijatrijskih bolesnika s Ph+ KML u blastičnoj krizi,
Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Insuficijencija bubrega: Bolesnici s poremećajem funkcije bubrega ili na dijalizi trebaju primati minimalnu preporučenu dozu od 400 mg na dan kao početnu dozu.
Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka Józefa Piłsudskiego 5
Pabianickie Zaklady Farmaceutyczne Polfa S.A. ul. Marszałka J. Pilsudskiego 5
All patients achieved complete haematological response, cytogenetic response and/or clinical response.
Svi su bolesnici postigli potpuni hematološki odgovor, citogenetski odgovor i/ili klinički odgovor.
Adverse reactions and their frequencies are reported in Table 1.
Nuspojave i njihove učestalosti navedene su u Tablici 1.
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥ 30 mg/kg/day.
U 2-godišnjoj studiji kancerogenosti u štakora primjena imatiniba od 15, 30 i 60 mg/kg/dan rezultirala je statistički značajnim smanjenjem dužine života mužjaka uz 60 mg/kg/dan i ženki uz ≥30 mg/kg/dan.
Partial
Djelomični
Liver dysfunction classification:
Klasifikacija poremećaja funkcije jetre:
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
• Hipereozinofilnog sindroma (HES) i/ili kronične eozinofilne leukemije (KEL).
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).
Maintenance (8-week cycles) Cycle 5
Održavanje (8-tjedni ciklusi) Ciklus 5
Induction therapy II
Indukcijska terapija II
Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric Hepatobiliary disorders
Ileus/intestinalna opstrukcija*, gastrointestinalna perforacija*, divertikulitis*, gastrična antralna vaskularna ektazija (GAVE)*
Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Slični rezultati uočeni su u bolesnika s malignim gliomima koji su liječeni imatinibom dok su uzimali antiepileptičke lijekove koji induciraju enzime, poput karbamazepina, okskarbazepina i fenitoina.
F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Nije bilo utjecaja na F1 fertilnost, dok je pri 45 mg/kg/dan zapažen povećani broj resorpcija i smanjeni broj fetusa sposobnih za život.
Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Bolesnici su liječeni s 340 mg/m²/dan imatiniba, bez prekida, u odsutnosti toksičnosti vezane uz dozu.
ANC < 1.0 x 10
ABN <1,0 x 10
Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
Ubrzana faza KML-a i blastična kriza te Ph+ ALL (početna doza 600 mg)
This was not seen at doses ≤ 20 mg/kg.
To nije uočeno pri dozama od ≤20 mg/kg.
For patients unable to swallow the capsules (e.g. paediatric patients), their content may be dispersed in a glass of still mineral water or apple juice.
Bolesnicima koji ne mogu progutati kapsule (npr. pedijatrijskim bolesnicima), sadržaj kapsule može se otopiti u čaši negazirane vode ili soka od jabuke.
In the event of overdose the patient should be observed and appropriate symptomatic treatment given.
U slučaju predoziranja, bolesnika treba promatrati i poduzeti odgovarajuće simptomatsko liječenje.
Long-term treatment with imatinib may be associated with a clinically significant decline in renal function.
Dugotrajno liječenje imatinibom može biti povezano s klinički značajnim padom funkcije bubrega.
These are a group of blood diseases in which some blood cells start growing out of control.
One čine skupinu bolesti krvi u kojima određene krvne stanice počinju nekontrolirano rasti.
These are blood diseases in which some blood cells (named eosinophils) start growing out of control.
To su bolesti krvi u kojima određene krvne stanice (zvane eozinofili) počinju nekontrolirano rasti.
340 mg/m daily is recommended for paediatric patients with chronic phase CML and accelerated phase CML (not to exceed the total dose of 800 mg).
Doza od 340 mg/m² na dan preporučuje se za pedijatrijske bolesnike s kroničnom fazom KML-a i s ubrzanom fazom KML-a (ne smije se prekoračiti ukupna doza od 800 mg).
What Imatinib medac is and what it is used for What you need to know before you take Imatinib medac
Što je Imatinib medac i za što se koristi Što morate znati prije nego počnete uzimati Imatinib medac Kako uzimati Imatinib medac
Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Insuficijencija jetre: imatinib se uglavnom metabolizira preko jetre.
If you forget to take Imatinib medac • If you forget a dose, take it as soon as you remember.
• Ako ste zaboravili dozu, uzmite ju čim se sjetite.
Teratogenic effects included exencephaly or encephalocele, absent/reduced frontal and absent parietal bones.
Teratogeni su učinci uključivali egzencefaliju ili encefalokelu, odsutnost/smanjenje čeonih i odsutnost tjemenih kostiju.
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Manje česte (mogu se javiti u do 1 na 100 osoba) ili rijetke (mogu se javiti u do 1 na 1000 osoba):
The dose can be reduced if not tolerated (see sections 4.4, 4.8 and 5.2).
Doza se može smanjiti ako se ne podnosi (vidjeti dijelove 4.4, 4.8 i 5.2).
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 (see section 4.5).
Od 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 (vidjeti dio 4.5).
Imatinib medac is a medicine containing an active substance called imatinib.
Imatinib medac je lijek koji sadrži djelatnu tvar zvanu imatinib.
In the juvenile toxicology study, effects upon growth, delay in vaginal opening and preputial separation were observed at approximately 0.3 to 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
U toksikološkim ispitivanjima mladih štakora, učinci na rast, odgode u otvaranju rodnice i separaciji prepucija uočeni su kod približno 0,3 do 2 puta veće izloženosti od pedijatrijske pri najvišoj preporučenoj dozi od 340 mg/m².
Study ADE04 Prephase
Studija ADE04 Predfaza
Muscular weakness, arthritis, rhabdomyolysis/myopathy
Slabost mišića, artritis, rabdomioliza/miopatija
If this applies to you, tell your doctor without taking Imatinib medac.
Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib medaca.
Clinical studies in DFSP
Klinička ispitivanja kod DFSP-a
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.
Imatinib medac can help you to fight this condition.
Imatinib medac Vam može pomoći u borbi protiv te bolesti.
In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/kg, approximately one-third the maximum human dose of 800 mg based on body surface.
U 39-tjednom ispitivanju na majmunima, NOAEL (razina kod koje se ne uočava štetan učinak) nije utvrđen pri najnižoj dozi od 15 mg/kg, koja iznosi približno jednu trećinu maksimalne doze za ljude od 800 mg temeljeno na veličini površine tijela.
• CML in the chronic phase after failure of interferon-alpha therapy, or in the accelerated phase.
• kronične mijeloične leukemije (KML) u kroničnoj fazi nakon neuspjeha liječenja interferonom alfa, ili u ubrzanoj fazi.
Clinical monitoring should be considered when administering imatinib to patients treated with metoprolol.
Potrebno je razmisliti o kliničkom nadzoru kada se imatinib primjenjuje u bolesnika liječenih metoprololom.
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).
6 puta veća u blastičnoj krizi i ubrzanoj fazi (59-64 % za neutropeniju i 44-63 % za trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7 % neutropenija i 8,9 % trombocitopenija).
Cataract, glaucoma, papilloedema
Katarakta, glaukom, papiloedem
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
Ako je bilo što abnormalno, na početku terapije je potrebno razmisliti o kontrolnom pregledu kod specijalista kardiologa i profilaktičkoj primjeni sistemskih steroida (1-2 mg/kg) tijekom jednog do dva tjedna istodobno uz imatinib.
Caution is recommended in thyroidectomy patients receiving levothyroxine and imatinib.
Preporučuje se oprez u bolesnika kojima je učinjena tireoidektomija, a primaju levotiroksin i imatinib.
* These types of reactions have been reported mainly from post-marketing experience with imatinib.
* Ove vrste reakcija zabilježene su uglavnom nakon stavljanja Imatinib medac u promet.
Carriers of HBV who require treatment with imatinib 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 imatiniba 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).
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
• odraslih bolesnika s uznapredovalim hipereozinofilnim sindromom (HES) i/ili kroničnom eozinofilnom leukemijom (KEL) s FIP1L1-PDGFRα preraspodjelom,
Neoplasm benign, malignant and unspecified (including cysts and polyps)
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Rijetko:
For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day can be given until disease progression occurs.
Za odrasle bolesnike s recidivirajućim ili refraktornim Ph+ ALL-om, monoterapija imatinibom u dozi od 600 mg/dan može se davati do pojave progresije bolesti.
Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
Ispitivanje AIT07 bilo je multicentrično, otvoreno, randomizirano ispitivanje faze II/III u kojem je sudjelovalo 128 bolesnika (od 1 do <18 godina) liječenih imatinibom u kombinaciji s kemoterapijom.
Imatinib medac 400 mg capsules are supplied in packs containing 30 capsules in blisters.
Imatinib medac 400 mg kapsule dostupne su u pakiranjima koja sadrže 30 kapsula u blisterima.
• Muscle cramps or joint, muscle or bone pain, during Imatinib medac treatment or after you have stopped taking Imatinib medac
• grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Imatinib medacom ili nakon prekida uzimanja Imatinib medaca
Other medicines and Imatinib medac
Drugi lijekovi i Imatinib medac
GERMANY
Njemačka
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
• znakovi infekcije kao što su vrućica, teška zimica, grlobolja ili čirevi u ustima.
These effects were not seen at doses ≤ 30 mg/kg.
Ti učinci nisu uočeni pri dozama od ≤30 mg/kg.
• Headache or feeling tired.
• glavobolja ili umor
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
Supstancija pokazuje in vivo antitumorsko djelovanje kao samostalni agens na životinjskim modelima u kojima se koriste Bcr-Abl pozitivne tumorske stanice.
A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
Ukupno 51 pedijatrijski bolesnik s novodijagnosticiranim i neliječenim KML-om u kroničnoj fazi uključen je u otvoreno, multicentrično, ispitivanje faze II s jednim krakom.
Clinical studies in HES/CEL
Klinička ispitivanja kod HES/KEL-a
Imatinib is a small molecule protein 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 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).
Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily.
Bolesnici s blagim, umjerenim ili teškim poremećajem funkcije jetre trebaju primati minimalnu preporučenu dozu od 400 mg na dan.
The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Klirens slobodnog imatiniba vjerojatno je u bolesnika s oštećenjem funkcije bubrega sličan onome u osoba s normalnom funkcijom bubrega jer izlučivanje putem bubrega predstavlja samo manje značajan put eliminacije za imatinib (vidjeti dijelove 4.2 i 4.4).
In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
U pedijatrijskih bolesnika s KML-om najčešće uočene toksičnosti bile su citopenije 3. ili 4. stupnja uključujući neutropeniju, trombocitopeniju i anemiju.
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 imatinib.
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 Imatinib medacom.
If your daily dose is 800 mg, you should take 1 capsule of 400 mg in the morning and 1 capsule of 400 mg in the evening.
Ako Vaša dnevna doza iznosi 800 mg morate uzeti 1 kapsulu od 400 mg ujutro i 1 kapsulu od 400 mg navečer.
Stop imatinib until ANC ≥ 1.5 x 10
Ukinuti imatinib sve dok ABN ne bude ≥1,5 x 10