natgillin/translations-raw huggingface dataset:
There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
U zdravih je ispitanika došlo do značajnog povećanja izloženosti imatinibu (srednji Cmax i AUC imatiniba povećali su se za 26 %, odnosno 40 %), kada je imatinib primjenjivan istodobno s jednokratnom dozom ketokonazola (CYP3A4 inhibitor).
1200 mg 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 mg do 1600 mg (trajanje je variralo između 1 do 10 dana): mučnina, povraćanje, proljev, osip, eritem, edem, oticanje, umor, mišićni spazam, trombocitopenija, pancitopenija, bol u trbuhu, glavobolja, smanjeni apetit.
• paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
• pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon neuspjeha terapije interferonom alfa, ili u ubrzanoj fazi,
Renal toxicity was observed in monkeys treated for 2 weeks, with focal mineralisation and dilation of the renal tubules and tubular nephrosis.
Bubrežna toksičnost je uočena u majmuna koji su liječeni 2 tjedna, uz fokalnu mineralizaciju i dilataciju bubrežnih kanalića i tubularnu nefrozu.
Pharmacokinetics in paediatric patients
Farmakokinetika u pedijatrijskih bolesnika
It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
Potrebno je imati na umu da bolesnici s GIST-om mogu imati metastaze u jetri koje mogu dovesti do oštećenja jetre.
• 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, bolovima/nelagodom u prsima, jako smanjenim mokrenjem i žeđi itd. (znakovi alergijske reakcije povezane s liječenjem).
Study ADE10 Prephase
Studija ADE10 Predfaza
Gastrointestinal haemorrhage
Gastrointestinalna krvarenja
Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Nuspojave zabilježene u više od jednoga izoliranog slučaja navedene su niže u tekstu po klasifikaciji organskih sustava i učestalosti.
One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhoea.
Kod jednog trogodišnjeg dječaka izloženog jednokratnoj dozi od 400 mg došlo je do povraćanja, proljeva i anoreksije, dok je kod drugog trogodišnjeg dječaka izloženog jednokratnoj dozi od 980 mg došlo do smanjenog broja leukocita i proljeva.
Continuous daily exposure to imatinib 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 imatinib (69.6 % vs. 31.6 %, respectively).
Stalna svakodnevna izloženost imatinibu u ranoj fazi liječenja u kombinaciji s kemoterapijom dovela je u bolesnika iz kohorte 5 (n=50) do poboljšanja stope 4-godišnjeg preživljenja bez događaja (EFS) u usporedbi s bolesnicima iz kontrolne kohorte (n=120), koji su primali standardnu kemoterapiju bez imatiniba (69,6 % u odnosu na 31,6 %).
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 imatinib (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-om bilo je uključeno u otvoreno, multicentrično, sekvencijsko kohortno, nerandomizirano ispitivanje faze III u kojem su primali imatinib (340 mg/m²/dan) u kombinaciji s intenzivnom kemoterapijom nakon indukcijskog liječenja.
6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
6400 mg (jednokratna doza): u literaturi je zabilježen jedan slučaj jednog bolesnika s mučninom, povraćanjem, bolovima u trbuhu, vrućicom, oticanjem lica, smanjenim brojem neutrofila, povišenjem vrijednosti transaminaza.
The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
Učinak imatiniba na ishod transplantacije koštane srži nije utvrđen.
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• kašalj, otežano disanje ili bolno disanje (znakovi plućnih problema)
6+7) Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
6+7) Bol u trbuhu i gastrointestinalno krvarenje najčešće su uočeni u bolesnika s GIST-om.
Close monitoring of growth in paediatric patients under treatment with imatinib is recommended (see section 4.8).
Preporučuje se pažljivo praćenje rasta u pedijatrijskih bolesnika koji se liječe imatinibom (vidjeti dio 4.8).
Imatinib 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.).
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.).
Dosing in paediatric patients at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Doziranje u pedijatrijskih bolesnika od 260 odnosno 340 mg/m²/dan postiglo je istu izloženost kao i doze od 400 mg i 600 mg u odraslih bolesnika.
Imatinib medac may cause your body to retain water (severe fluid retention).
Imatinib medac može izazvati zadržavanje vode u tijelu (teška retencija tekućine).
In the event of overdose, the patient should be observed and appropriate supportive treatment given.
U slučaju predoziranja, potrebno je promatrati bolesnika i provoditi odgovarajuće suportivno liječenje.
In an oral pre- and postnatal development study in rats, red vaginal discharge was noted in the 45 mg/kg/day group on either day 14 or day 15 of gestation.
U ispitivanju prenatalnog i postnatalnog razvoja u štakora, uočen je crveni vaginalni iscjedak u skupini koja je peroralno primala 45 mg/kg/dan bilo na 14. bilo na 15. dan gestacije.
There are no controlled trials in paediatric patients with MDS/MPD.
Nema kontroliranih ispitivanja u pedijatrijskih bolesnika s MDS/MPD-om.
The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Povećanje je od približno 1,5 do 2 puta što odgovara povećanju alfakiselog glikoproteina (AGP) u plazmi, proteina na koji se imatinib čvrsto veže, od 1,5 puta.
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Pedijatrijska ubrzana faza KML-a i blastična kriza (početna doza 340 mg/m²)
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
Unutar svake grupe učestalosti, nuspojave su prikazane prema redosljedu učestalosti, najučestalije su prve.
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 section 4.8).
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).
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 DFSP.
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-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 DFSP-om.
Your doctor will discuss with you the possible risks of taking Imatinib medac during
Liječnik će Vam objasniti moguće rizike od uzimanja Imatinib medaca tijekom trudnoće.
• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
• odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim bolestima (MDS/MPD) povezanim s preraspodjelom gena za receptor za faktor rasta koji potječe od trombocita (PDGFR),
3) On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
3) Na temelju procjene bolesnik-godina, srčani događaji uključujući kongestivno zatajenje srca bili su češće uočeni u bolesnika s transformiranim KML-om, nego u bolesnika s kroničnim KML-om.
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, i za faktor matičnih stanica (SCF), c-Kit, te inhibira stanične događaje do kojih dolazi posredstvom PDGF-a i SCF-a.
The active substance imatinib demonstrates an environmental risk for sediment organisms.
Djelatna tvar imatinib predstavlja rizik za okoliš za organizme koji žive u sedimentnom tlu.
There are no controlled trials in paediatric patients with DFSP.
Nema kontroliranih ispitivanja u pedijatrijskih bolesnika s DFSP-om.
Pericarditis*, cardiac tamponade* Vascular disorders
Perikarditis*, tamponada srca*
The age of these patients ranged from 25 to 72 years.
Dob tih bolesnika kretala se od 25 do 72 godine.
This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Ovo je kliničko ispitivanje uključivalo 7 bolesnika s MDS/MPD-om koji su liječeni imatinibom od 400 mg na dan.
Thyroid-stimulating hormone (TSH) levels should be closely monitored in such patients.
U takvih bolesnika treba pažljivo pratiti razine tireotropina (TSH).
Maximal plasma concentrations of imatinib in patients are 2-4 μmol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered medicinal products is possible.
Maksimalne koncentracije imatiniba u plazmi bolesnika iznose 2-4 µmol/l pa je prema tome moguća inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
The age of these patients ranged from 2 to 79 years.
Dob tih bolesnika kretala se od 2 do 79 godina.
If you take more Imatinib medac than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Ako ste zabunom uzeli previše kapsula, odmah se obratite liječniku.
The no observed effect level (NOEL) was 30 mg/kg/day.
Razina kod koje se ne uočava učinak (NOEL) iznosila je 30 mg/kg/dan.
• Patients who are concerned about their fertility while taking Imatinib medac are advised to
• Bolesnicima koji su zabrinuti za svoju plodnost tijekom uzimanja Imatinib medaca preporučuje se da se posavjetuju sa svojim liječnikom.
Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
U bolesnika koji su kronični nositelji virusa hepatitisa B pojavila se ponovna aktivacija tog virusa nakon što su primili inhibitore BCR-ABL tirozin kinaze.
In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Imatinib in vitro inhibira aktivnost CYP2D6 izoenzima citokroma P450 u koncentracijama koje su slične onima što utječu na djelovanje CYP3A4.
In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intratumoural haemorrhages were reported (see section 4.8).
U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om zabilježena su i gastrointestinalna i intratumorska krvarenja (vidjeti dio 4.8).
• 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 žarenjem
Dizziness, paraesthesia, taste disturbance, hypoaesthesia
Omaglica, parestezija, poremećaj okusa, hipoestezija
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 paediatric patients (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 pedijatrijskih bolesnika (temeljeno na AUC) kod 340 mg/m²/dan.
Superficial oedemas were a common finding in all studies and were described primarily as periorbital or lower limb oedemas.
U svim su ispitivanjima površinski edemi bili čest nalaz, a opisani su u prvome redu kao periorbitalni edemi ili kao edemi donjih ekstremiteta.
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 paediatric patients (based on AUC) at 340 mg/m2/day.
Papilom/karcinom žlijezde prepucija/klitorisa zabilježeni su 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 pedijatrijskih bolesnika (temeljeno na AUC) kod 340 mg/m²/dan.
6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
6-MP (75 mg/m²/dan, p.o.): dani 11-56 (Uskratiti 6-MP tijekom 6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1. dana nakon završetka kranijalne iradijacije.)
9/l, then resume treatment at 200 mg/m
9/l, nakon toga nastaviti liječenje u dozi od 200 mg/m².
Chronic phase CML, MDS/MPD (starting dose 400 mg)
Kronična faza KML-a, MDS/MPD-a (početna doza 400 mg) HES/KEL (doza od 400 mg)
Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or < ULN if total bilirubin is >ULN)
AST: >GGN (može biti normalan ili <GGN ako je ukupni
A further 6 DFSP patients treated with imatinib 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 imatinibom, s rasponom dobi od 18 mjeseci do 49 godina.
There were no special safety findings in paediatric clinical trials.
U pedijatrijskim kliničkim ispitivanjima nije bilo posebnih nalaza o sigurnosti primjene.
The age of these patients ranged from 20 to 72 years.
Dob tih bolesnika se kretala od 20 do 72 godine.
The no observed effect level (NOEL) was 15 mg/kg/day.
Razina kod koje se ne uočava učinak (NOEL) iznosila je 15 mg/kg/dan.
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).
2) Headache was the most common in GIST patients.
2) Glavobolja je bila najčešća u bolesnika s GIST-om.
NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
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If cytopenia persists for 2 weeks, reduce further to 300 mg.
3. Ako citopenija ustraje 2 tjedna, dozu ponovno smanjiti na 300 mg.
Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control.
Akutna limfoblastična leukemija je oblik leukemije u kojem određene abnormalne bijele krvne stanice (zvane limfoblasti) počinju nekontrolirano rasti.
The usual starting dose in treatment in CML in blast crisis is 600 mg, to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Uobičajena početna doza za liječenje KML u blastičnoj krizi iznosi 600 mg, a uzima se jednom na dan kao 6 kapsula od 100 mg (ili 1 kapsula od 400 mg i 2 kapsule od 100 mg).
There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
U KML bolesnika uočen je veći postotak mijelosupresije nego u bolesnika s GIST-om, što je vjerojatno uzrokovano osnovnom bolešću.
Clinical studies in Ph+ ALL
Klinička ispitivanja kod Ph+ ALL-a
One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib 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 imatiniba u raznim populacijama bolesnika koji pate od bolesti opasnih po život povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
The plasma AUC for imatinib decreased by 73 % compared to patients not on EIAEDs.
AUC imatiniba u plazmi smanjio se za 73 % u usporedbi s bolesnicima koji nisu primali antiepileptičke lijekove koji induciraju enzime.
In the F1 offspring, at the same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased.
Pri istoj dozi povećao se broj mrtvorođenih mladunaca, kao i onih koji su uginuli postpartalno između dana 0 i 4. U F1 potomstva, pri istoj dozi, smanjile su se srednje tjelesne težine od poroda sve do konačnog žrtvovanja, a broj okota koji su postigli kriterij za prepucijsku separaciju bio je malo smanjen.
In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
U ispitivanju fertilnosti, u mužjaka štakora koji su primali dozu tijekom 70 dana prije parenja, smanjila se težina testisa i epididimisa te postotak pokretljive sperme uz dozu od 60 mg/kg, što je približno jednako maksimalnoj kliničkoj dozi od 800 mg/dan, temeljeno na veličini površine tijela.
This will help protect you from stomach problems when
To će Vam pomoći u zaštiti od želučanih problema prilikom uzimanja Imatinib medaca.
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 %.
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Hipokalijemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija, giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatrijemija
The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Doza se može smanjiti ako se ne podnosi (vidjeti dijelove 4.2 i 5.2).
Population pharmacokinetics
Farmakokinetika populacije
Active substances that may have their plasma concentration altered by imatinib 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 imatinib 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.
Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib.
Bolesnike treba obavijestiti o postojanju mogućnosti da tijekom liječenja imatinibom nastupe nuspojave poput omaglice, zamagljenog vida ili somnolencije.
Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.
Kronična mijeloična leukemija je oblik leukemije u kojem određene abnormalne bijele krvne stanice (zvane mijeloidne stanice) počinju nekontrolirano rasti.
Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Hipertenzija, hematom, subduralni hematom, periferna hladnoća, hipotenzija, Raynaudov fenomen
Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Povećanja doze od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s blastičnom krizom može se razmotriti u odsutnosti teške nuspojave i teške neutropenije ili trombocitopenije nepovezane s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
MARKETING AUTHORISATION NUMBER (S) EU/1/13/876/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/876/001
Do not take Imatinib medac: • if you are allergic to imatinib or any of the other ingredients of this medicine (listed in
• ako ste alergični na imatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).