natgillin/translations-raw huggingface dataset:
Although renal excretion is not a major route of ponatinib elimination, the potential for moderate or severe renal impairment to affect hepatic elimination has not been determined (see section 4.2).
Iako izlučivanje putem bubrega nije glavni put eliminacije ponatiniba, moguć utjecaj umjerenog ili teškog oštećenja bubrega na eliminaciju putem jetre nije utvrđen (vidjeti dio 4.2).
Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled.
Liječenje Iclusigom se mora privremeno prekinuti ako se hipertenzija ne kontrolira lijekovima.
For all patients in the phase 2 trial, the dose intensity-safety relationship indicated that there are significant increases in grade ≥ 3 adverse events (cardiac failure, arterial thrombosis, hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression) over the dose range of 15 to 45 mg once-daily.
Za sve bolesnike u ispitivanju faze 2, odnos jačina doze-sigurnost ukazao je na značajna povećanja štetnih događaja stupnja ≥ 3 (zatajenje srca, arterijska tromboza, hipertenzija, trombocitopenija, pankreatitis, neutropenija, osip, povećanje ALT, povećanje AST, povećanje lipaze, mijelosupresija) u rasponu doze od 15 do 45 mg jednom dnevno.
All patients were administered 45 mg of Iclusig once-daily with the possibility of dose de-escalations and dose interruptions followed by dose resumption and re-escalation.
Svi bolesnici primili su 45 mg lijeka Iclusig jednom dnevno s mogućnosti smanjenja doze i prekida doze, a potom ponovni nastavak doziranja i povišenje doze.
Grade 3 or 4 asymptomatic elevation of lipase/amylase (> 2.0 x IULN*) only
Samo asimptomatsko povišenje lipaze/amilaze 3. ili 4. stupnja (> 2,0 x IGGN*)
Fatal and serious heart failure or left ventricular dysfunction occurred in Iclusig-treated patients, including events related to prior vascular occlusive events.
Smrtonosno i ozbiljno zatajenje srca ili disfunkcija lijeve klijetke javili su se u bolesnika liječenih Iclusigom, uključujući i događaje povezane s ranijim događajima vaskularne okluzije.
Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig.
Pratite bolesnike zbog otkrivanja znakova i simptoma koji ukazuju na zatajenje srca i liječite ih sukladno kliničkoj indikaciji, uključujući i prekid davanja Iclusiga.
• narrowing of the arteries in the brain
• suženje arterija u mozgu
In the event of an overdose of Iclusig, the patient should be observed and appropriate supportive treatment given.
U slučaju predoziranja lijekom Iclusig bolesnike treba nadzirati i primijeniti odgovarajuće potporne mjere liječenja.
Anaemia (Hgb decreased)
Anemija (snižen Hgb)
Liver function abnormality
Abnormalna jetrena funkcija
Multiple foetal soft tissue and skeletal alterations were also observed at maternal nontoxic dosages.
Višestruke izmjene mekog tkiva i kostura fetusa također su uočene pri dozama koje nisu bile toksične za majku.
In a cell-based accelerated mutagenesis assay, no mutation in BCR-ABL was detected that could confer resistance to 40 nM ponatinib.
U ubrzanom testu mutagenosti provedenom na stanicama nisu uočene BCR-ABL mutacije koje bi prouzrokovale rezistenciju na 40 nM ponatiniba.
Overall, the most common adverse reactions (≥20%) were platelet count decreased, rash, dry skin, and abdominal pain.
Ukupno gledano najčešće nuspojave (≥20%) bile su pad broja trombocita, osip, suha koža i bol u abdomenu.
Consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days).
Razmotrite prekid davanja ponatiniba ako se potpuni hematološki odgovor ne javi za 3 mjeseca (90 dana).
Ponatinib is mainly eliminated via faeces.
Ponatinib se uglavnom uklanja fecesom.
Of the CP-CML patients with no mutation detected at entry, 46% (63/136) achieved a MCyR.
Od ukupnog broja bolesnika u kroničnoj fazi KML bez mutacija prilikom uključivanja, 46% (63/136) postiglo je MCyR.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 3000, polyvinyl alcohol, titanium dioxide (E171).
• Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, natrijev škroboglikolat, silicijev dioksid (koloidni bezvodni), magnezijev stearat, talk, makrogol 4000, poli(vinilni alkohol), titanijev dioksid (E171).
• narrowing of the blood vessels, poor blood circulation
• suženje krvnih žila, slaba cirkulacija krvi
The QT interval prolongation potential of Iclusig was assessed in 39 leukaemia patients and no clinically significant QT prolongation was observed (see section 5.1).
Utjecaj lijeka Inclusig na produljenje QT intervala ispitano je u 39 bolesnika s leukemijom te nije uočeno značajno produljenje QT intervala (vidjeti dio 5.1).
ARIAD Pharma Ltd. Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD United Kingdom
Riverbridge House Guildford Road Leatherhead Surrey KT22 9AD Velika Britanija
Haematological Response Rate Majora (MaHR)
Stopa hematološkog odgovora Značajana (MaHR)
Consider discontinuation of ponatinib in patients who develop serious heart failure (see sections 4.2 and 4.8).
Razmotrite prekid davanja ponatiniba u bolesnika kod kojih se razvije ozbiljno zatajenje srca (vidjeti dijelove 4.2 i 4.8).
• chronic myeloid leukaemia (CML): a blood cancer involving too many abnormal white blood cells in the blood and the bone marrow (where blood cells are formed).
• kroničnom mijeloičnom leukemijom (KML): rakom krvi s previše nenormalnih bijelih krvnih stanica u krvi i koštanoj srži (u kojoj se stvaraju krvne stanice).
Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases.
Ponatinib inhibira aktivnost drugih klinički značajnih kinaza s vrijednostima IC50 ispod 20 nM i dokazano smanjuje aktivnost RET, FLT3 i KIT te članova obitelji kinaza FGFR, PDGFR i VEGFR.
• increased blood sugar or uric acid levels in the blood, high blood fat values of triglycerides
• povišene razine šećera ili mokraćne kiseline u krvi, visoke razine triglicerida u krvi
Patients with estimated creatinine clearance of ≥ 50 mL/min should be able to safely receive Iclusig with no dosage adjustment.
Bolesnici s klirensom kreatinina ≥ 50 ml/min mogu primati Iclusig bez prilagodbe doze.
• a liver or pancreas disorder or reduced kidney function.
• poremećaj jetre ili gušterače ili smanjenu funkciju bubrega
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
Liječenje treba provesti liječnik s iskustvom u dijagnosticiranju i liječenju bolesnika s leukemijom.
Very common alanine aminotransferase increased, aspartate aminotransferase increased
Vrlo često povišena alanin aminotransferaza, povišena aspartat aminotransferaza
Very common hypertension
Vrlo često hipertenzija
The geometric mean (CV%) Cmax and AUC(0-τ) exposures achieved for ponatinib 45 mg daily at steady state were 77 ng/mL (50%) and 1296 ng•hr/mL (48%), respectively.
Geometrijska sredina (CV%) Cmax i AUC(0-τ) izloženosti postignute za ponatinib 45 mg dnevno u stanju dinamičke ravnoteže je 77 ng/ml (50%) odnosno 1296 ng•hr/ml (48%).
• increased blood level of bilirubin - the yellow breakdown substance of the blood pigment
• povišena razina bilirubina u krvi - žuti razgradni produkt krvnog pigmenta
Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
Iclusig može uzrokovati porast vrijednosti ALT-a, AST-a, bilirubina i alkalne fosfataze.
PHARMACEUTICAL FORM AND CONTENTS 60 tablets
OBLIK I SADRŽAJ 60 tableta
• dabigatran: a medicine to prevent the formation of blood clots.
• dabigatran: lijek za sprječavanje nastanka krvnih ugrušaka.
- increased levels of the serum proteins lipase or amylase.
- povišene razine proteina lipaza ili amilaza u serumu.
A prior MCyR or better (MCyR, MMR, or CMR) to dasatinib or nilotinib was only achieved in 26% patients with CP-CML and a prior MaHR or better (MaHR, MCyR, MMR, or CMR) was only achieved in 21%, and 24% of AP-CML, and BP-CML/Ph+ALL patients, respectively.
Prethodni MCyR ili bolji (MCyR, MMR ili CMR) odgovor na dasatinib ili nilotinib postignut je samo u 26% bolesnika u kroničnoj fazi KML, a prethodni MaHR ili bolji (MaHR, MCyR, MMR ili CMR) postignut je samo u 21% odnosno u 24% bolesnika u ubrzanoj fazi KML odnosno blastičnoj fazi KML/Ph+ ALL.
In vitro studies suggested that ponatinib is either not a substrate or is a weak substrate for both P-gp and breast cancer resistance protein BCRP.
In vitro ispitivanja ukazala su da ponatinib nije supstrat ili da je slabi supstrat i za P-gp i za protein rezistencije karcinoma dojke BCRP.
• obstruction of the blood vessels in the eye, visual disturbance
• začepljenje krvnih žila u oku, poremećaj vida
Iclusig should not be used in patients with a history of myocardial infarction, prior revascularization or stroke, unless the potential benefit of treatment outweighs the potential risk (see sections 4.2 and 4.8).
Iclusig se ne smije koristiti u bolesnika s anamnezom infarkta miokarda, prethodne revaskularizacije ili moždanog udara, osim ako potencijalna korist ne nadjačava potencijalni rizik (vidjeti dio 4.2 i 4.8).
In the case of severe adverse reactions, treatment should be withheld.
U slučaju teških nuspojava liječenje treba prekinuti.
For every BCR-ABL mutation detected in more than one CP-CML patient at entry, a MCyR was achieved following treatment with Iclusig.
Za svaku mutaciju BCR-ABL mutaciju uočenu na početku istraživanja u više od jednog bolesnika u kroničnoj fazi KML, MCyR je postignut nakon liječenja lijekom Iclusig.
ALT=alanine aminotransferase, ANC=absolute neutrophil count, AST=aspartate aminotransferase, Hgb=haemoglobin, WBC=white blood cell count.
ALT=alanin aminotransferaza, ABN=apsolutni broj neutrofila, AST=aspartat aminotransferaza, Hgb=hemoglobin, Lkc= leukociti.
The adverse reactions described in this section were identified in a single-arm, open-label, international, multicenter trial in 449 CML and Ph+ ALL patients who were resistant or intolerant to prior TKI therapy including those with a BCR-ABL T315I mutation.
Nuspojave navedene u ovom poglavlju opisane su u otvorenom, međunarodnom, multicentričnom ispitivanju na jednoj skupini u kojem je sudjelovalo 449 bolesnika s KML i Ph+ ALL rezistentnih ili intolerantnih na prethodno liječenje TKI uključujući i bolesnike s mutacijom BCR-ABL T3151.
Co administration of strong CYP3A4 inducers such as carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's Wort with ponatinib should be avoided, and alternatives to the CYP3A4 inducer should be sought, unless the benefit outweighs the possible risk of ponatinib underexposure.
Istovremenu primjenu snažnih CYP3A4 induktora kao što su karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin, i gospina trava s ponatinibom treba izbjegavati, te potražiti alternative CYP3A4 induktoru, osim ako su koristi veće od mogućeg rizika smanjene izloženosti ponatinibu.
(95% CI) Completeb (CHR)
(95% CI) Kompletnib (CHR)
In preclinical mutagenesis studies, 40 nM was determined as the concentration of ponatinib sufficient to inhibit viability of cells expressing all tested BCR-ABL mutants by >50% (including T315I) and suppress the emergence of mutant clones.
U pretkliničkim ispitivanjima mutagenosti, 40 nM je određeno kao koncentracija ponatiniba koja je dovoljna za inhibiciju više od 50% vijabilnosti stanica koje eksprimiraju sve testirane mutacije BCR-ABL (uključujući T315I) i potiskivanje nadiranja mutantskih klonova.
In rats, inflammatory changes accompanied by increases in neutrophils, monocytes, eosinophils, and fibrinogen levels were found in the preputial and clitoral glands following chronic dosing.
U štakora su uočene upalne promjene popraćene porastom broja neutrofila, monocita, eozinofila i fibrinogena u žlijezdama prepucija i klitorisa nakon kroničnog doziranja.
Defined as a ≤0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript), in peripheral blood measured by quantitative reverse transcriptase polymerase chain reaction (qRT PCR).
Definiran kao omjer ≤0,1% BCR-ABL na ABL prijepise na međunarodnoj ljestvici (IS) (primjerice, ≤0,1% BCR-ABLIS; bolesnici moraju imati prijepis b2a2/b3a2 (p210)), u perifernoj krvi mjeren kvantitativno pomoću reakcije lančane polimeraze (qRT PCR).
The safety and efficacy of Iclusig in CML and Ph+ ALL patients who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy were evaluated in a single-arm, open-label, international, multicenter trial.
Sigurnost i djelotvornost primjene ponatiniba u bolesnika s KML i Ph+ALL koji su bili rezistentni ili intolerantni na prethodna liječenja inhibitorima tirozin kinaze (TKI) procijenjeni su u otvorenom, međunarodnom, multicentričnom ispitivanju s jednom skupinom bolesnika.
At daily doses of 45 mg, the geometric mean (CV%) apparent steady state volume of distribution is 1101 L (94%) suggesting that ponatinib is extensively distributed in the extravascular space.
Pri dnevnim dozama od 45 mg geometrijska sredina (CV%) prividnog volumena distribucije u stanju dinamičke ravnoteže je 1101 l (94%) što govori da se ponatinib široko raspodjeljuje u ekstravaskularni prostor.
A reduction of the starting dose of Iclusig in patients with hepatic impairment is not necessary (see sections 4.2 and 4.4).
Smanjenje početne doze lijeka Iclusig u bolesnika s oštećenjem jetre nije potrebno (vidjeti dijelove 4.2 i 4.4).
• fatigue, accumulation of fluid in arms and/or legs, fever, pain
• umor, nakupljanje tekućine u rukama i/ili nogama, vrućica, bol
Patients were assigned to one of six cohorts based on disease phase (CP-CML; AP-CML; or BP-CML/Ph+ ALL), resistance or intolerance (R/I) to dasatinib or nilotinib, and the presence of the T315I mutation.
Bolesnici su dodijeljeni u jednu od 6 kohorti na temelju faze bolesti (KML-kronična faza; KML-ubrzana faza; ili KML-blastična kriza/Ph+ ALL), rezistencija ili intolerancija (R/I) na dasatinib ili nilotinib i na prisutnost mutacije T315I.
Further data on maintenance of response are required in order to make a formal recommendation for dose modifications in the absence of an adverse event as a risk minimisation strategy (see sections 4.2 and 4.4).
Za formalnu preporuku prilagodbe doze u odsustvu štetnih događaja kao strategije minimizacije rizika potrebni su daljnji podatci o održavanju odgovora (vidjeti dijelove 4.2 i 4.4).
Very common rash, dry skin
Vrlo često osip, suha koža
The rates of treatment-related adverse events resulting in discontinuation were 14% in CP-CML, 7% in APCML and 4% in BP-CML/Ph+ ALL.
Stope nuspojava povezanih s liječenjem koje su rezultirale u prekidu liječenja iznosile su 14% u CP-KML, a 7% u AP-KML te 4% u BP-KML/Ph+ALL.
Haematological Response Rate
Stopa hematološkog odgovora
Lipase increased
Povišena lipaza
Table 3 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Tablica 3 Nuspojave uočene u KML i Ph+ ALL bolesnika - učestalost prijavljena prema incidenciji događaja izazvanih liječenjem Klasifikacija organskih sustava
Bottles of Iclusig 45 mg contain either 30 or 90 film-coated tablets.
Boca Iclusiga 45 mg sadrži 30 ili 90 filmom obloženih tableta.
Ponatinib at doses of 3, 10, and 30 mg/kg produced increases in urine output and electrolyte excretions and caused a decrease in gastric emptying in safety pharmacology studies in rats.
Ponatinib u dozama 3, 10 i 30 mg/kg proizveo je porast u stvaranju mokraće i izlučivanju elektrolita te je uzrokovao smanjenje u pražnjenju želuca u studijama sigurnosne farmakologije u štakora.
Overall (N=83)
Ukupno (N=83)
• lethargy, migraine
• letargija, migrena
• breathing difficulties
• otežano disanje
Overall, 55% of patients had one or more BCR-ABL kinase domain mutation at entry with the most frequent being: T315I (29%), F317L (8%), E255K (4%) and E359V (4%).
Najčešće mutacije su: T315I (29%), F317L (8%), E255K (4%) i E359V (4%).
Check serum lipase every 2 weeks for the first 2 months and then periodically thereafter.
Serumsku lipazu treba kontrolirati svaka 2 tjedna tijekom prva 2 mjeseca a zatim periodično.
Effective contraception must be used during treatment.
Tijekom liječenja potrebno je koristiti djelotvornu kontracepciju.
Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled (see section 4.2).
Liječenje Iclusigom se mora privremeno prekinuti ako se hipertenzija ne kontrolira lijekovima (vidjeti dio 4.2).
Discontinue Iclusig *IULN = institution upper limit of normal
Prekid liječenja lijekom Iclusig *IGGN = gornja granica normalnih vrijednosti ustanove
Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4.5%, neutropenia and anaemia <1% each).
Prekid terapije zbog mijelosupresije nisu bili česti (trombocitopenija 4,5%, neutropenija i anemija <1% svaka).
Of the CP-CML patients previously treated with one, two, or three prior TKIs, 81% (13/16), 61% (65/105), and 46% (66/143) achieved a MCyR while on Iclusig, respectively.
Od bolesnika u kroničnoj fazi KML koji su prethodno liječeni s jednim, dva ili tri TKI, 81% (13/16), 61% (65/105) odnosno s 46% (66/143) postigli su MCyR dok su se liječili lijekom Iclusig.
Common erectile dysfunction
Često erektilna disfunkcija
Bottles of Iclusig 15 mg contain either 60 or 180 film-coated tablets.
Boca Iclusiga 15 mg sadrži 60 ili 180 filmom obloženih tableta.
• low calcium, phosphate or potassium levels in the blood
• niske razine kalcija, fosfata ili kalija u krvi
ANC* < 1.0 x 109/L or platelet < 50 x 109/L
ABN* < 1,0 x 109/l ili trombociti < 50 x 109/l
In the phase 2 trial, 87 CP-CML patients achieved MCyR at a dose of 45 mg, 45 CP-CML patients achieved MCyR after a dose reduction to 30 mg, mostly for adverse events.
U ispitivanju faze 2, 87 bolesnika u kroničnoj fazi KML postiglo je MCyR pri dozi od 45 mg , 45 bolesnika s kroničnom fazom KML postiglo je MCyR nakon smanjenja doze na 30 mg, uglavnom zbog štetnih događaja.
Co-administration of Iclusig with a potent inhibitor of gastric acid secretion resulted in a minor reduction in ponatinib Cmax without a reduction in AUC0-∞.
Istovremena primjena lijeka Iclusig s jakim inhibitorima izlučivanja želučane kiseline rezultirala je manjim smanjenjem Cmax ponatiniba bez smanjenja AUC0-∞.
In rats, embryo-foetal toxicity in the form of post-implantation loss, reduced foetal body weight, and multiple soft tissue and skeletal alterations were observed at maternal toxic dosages.
U štakora je embriofetalna toksičnost u obliku propadanja zametka nakon implantacije, smanjenje tjelesne težine fetusa i višestruke izmjene na mekom tkivu i kosturu uočene su pri dozama koje su bile toksične za majku.
Alkaline phosphatase increased
Povišena alkalna fosfataza
Ponatinib Cmax was comparable in patients with mild hepatic impairment and healthy volunteers with normal hepatic function.
Cmax ponatiniba bio je sličan u bolesnika s blagim oštećenjem jetre i zdravih dobrovoljaca s normalnom funkcijom jetre.
The recommended starting dose is 45 mg of ponatinib once daily.
Preporučena početna doza iznosi 45 mg ponatiniba, jednom dnevno.
Patients should be advised not to swallow the desiccant canister found in the bottle.
Bolesnike treba savjetovati da ne progutaju spremnik sa sredstvom za sušenje koji se nalazi u boci.
Liver function tests should be performed prior to treatment initiation and monitored periodically, as clinically indicated.
Potrebne su kontrole jetrene funkcije prije uvođenja liječenja i povremeno praćenje, kako je klinički indicirano.
Factors to take into account if considering dose reduction in CP-CML patients who have achieved a MCyR in the absence of an adverse event.
Čimbenici koje treba uzeti u obzir ako se razmatra smanjenje doze u bolesnika s kroničnom fazom KML koji su postigli MCyR u odsustvu štetnog događaja.
Ponatinib-related microscopic findings in the ovaries (increased follicular atresia) and testes (minimal germ cell degeneration) in animals treated with 5 mg/kg ponatinib were noted in repeat-dose toxicity studies in cynomolgus monkeys.
S ponatinibom povezani mikroskopski nalazi jajnika (povećana atrezija folikula) i testisa (minimalna degeneracija spolnih stanica) u životinja liječenih s 5 mg/kg ponatiniba uočeni su u studijama toksičnosti ponovljene doze u makaki majmuna.
In cynomolgus monkeys, systolic heart murmurs with no macroscopic or microscopic correlates were noted in individual animals treated with 5 and 45 mg/kg in the single dose toxicity study and at 1, 2.5 and 5 mg/kg in the 4-week repeat-dose toxicity study.
U makaki majmuna uočeni su sistolički šumovi srca bez makroskopkih ili mikroskopskih povezanosti s pojedinim životinjama liječenih s 5 i 45 mg/kg u studiji toksičnosti pojedinačne doze i u studiji toksičnosti ponovljene doze koja je trajala 4 tjedna i uključivala doze od 1, 2,5 i 5 mg/kg.
Skin changes in the form of crusts, hyperkeratosis, or erythema were observed in toxicity studies in cynomolgus monkeys.
Kožne promjene u obliku krasta, hiperkeratoze ili eritema uočene su u studijama toksičnosti u makaki majmuna.
Recurrence at 30 mg:
Ponovna pojava uz 30 mg:
Unchanged ponatinib accounted for 24% and <1% of the administered dose in faeces and urine, respectively, with the remainder of the dose comprising metabolites.
Nepromijenjeni ponatinib predstavlja 24% i manje od 1% primijenjene doze u fecesu odnosno u mokraći s preostalom doza koju sačinjavaju metaboliti.
Medicinal product interactions
Interakcije lijekova
Gender, race and body weight were not predictive in explaining ponatinib pharmacokinetic intersubject variability.
Spol, rasa i tjelesna masa nisu bile predskazujuće u farmakokinetskoj varijabilnosti ponatiniba između ispitanika.
The primary efficacy endpoint in CP-CML was major cytogenetic response (MCyR), which included complete and partial cytogenetic responses (CCyR and PCyR).
Primarni ishod za bolesnike u kroničnoj fazi KML bio je značajni citogenetički odgovor (MCyR, engl. major cytogenetic response) koji je uključivao kompletni i parcijalni citogenetički odgovor (CCyR i PCyR, engl. complete and partial cytogenetic responses).
• methotrexate: a medicine to treat severe joint inflammation (rheumatoid arthritis), cancer and the skin disease psoriasis.
• metotreksat: lijek za liječenje teške upale zglobova (reumatoidni artritis), karcinoma i kožne bolesti psorijaze.
Iclusig is available in plastic bottles, each containing one canister of molecular sieve desiccant.
Iclusig je dostupan u plastičnim bocama, od kojih svaka sadrži jedan spremnik s molekularnim sitom kao sredstvom za sušenje.
• insomnia
• nesanica
Overall (N=62)
Ukupno (N=62)
• mini stroke, cerebral infarction
• mali moždani udar, moždani infarkt
Glucose increased
Povišena glukoza
• a severe side effect occurs, not affecting the blood
• ako dođe do teških nuspojava koje ne zahvaćaju krv
Common blood bilirubin increased, blood alkaline phosphatase increased, gammaglutamyltransferase increased
Često povišen bilirubin u krvi, povišena alkalna fosfataza u krvi, povišena gama-glutamil transferaza
• stomach bleeding (symptoms include: stomach pain, vomiting blood)
• krvarenje iz želuca (simptomi uključuju: bol u želucu, povraćanje krvi)
• blood clot in a deep vein, sudden vein obstruction, blood clot in a blood vessel of the lung (symptoms include: hot flush, flushing, redness of the face, breathing difficulty)
• krvni ugrušak u dubokim venama, iznenadno začepljenje vena, krvni ugrušak u krvnim žilama pluća (simptomi uključuju: navale vrućine, nalete crvenila, crvenilo lica, otežano disanje)
The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Incidencija događaja ozbiljnog krvarenja bila je viša u bolesnika s AP-KML, BPKML, i Ph+ ALL.