FrancophonIA/ELRC3.0 huggingface dataset:
English: Tablet core
Slovenian: odmerna žlička
English: Do not breast-feed while using Noxafil.
Slovenian: Med zdravljenjem z zdravilom Noxafil ne dojite.
English: Posaconazole plasma concentrations following administration of posaconazole tablets are generally higher than those obtained with posaconazole oral suspension.
Slovenian: Koncentracije posakonazola v plazmi so po uporabi tablet običajno večje kot po uporabi peroralne suspenzije.
English: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.
Slovenian: Zdravilo Noxafil koncentrat za raztopino za infundiranje je indicirano tudi za profilakso invazivnih glivnih okužb pri: - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS) in pri katerih se zato pričakuje dolgotrajnejša nevtropenija ter imajo veliko tveganje za invazivne glivne okužbe, - prejemnikih presajenih hematopoetskih matičnih celic (HSCT), ki zaradi preprečevanja reakcije presadka proti gostitelju (GVHD) prejemajo visokoodmerno imunosupresivno zdravljenje in pri katerih obstaja veliko tveganje za invazivne glivne okužbe.
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: How to store Noxafil
Slovenian: Shranjevanje zdravila Noxafil
English: • if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.
Slovenian: ki vsebuje alkaloide ergot (na primer ergotamin ali dihidroergotamin) ali kakšen statin, na primer simvastatin, atorvastatin ali lovastatin.
English: August 2021
Slovenian: avgust 2021
English: Vascular occlusive events occurred in 44 of these 131 patients.
Slovenian: Vaskularni okluzivni dogodki so se pojavili pri 44 od teh 131 bolnikov.
English: • an appropriate response to the treatment is reached
Slovenian: • je dosežen ustrezen odziv na zdravljenje;
English: 4879 AC Etten-Leur Netherlands
Slovenian: 4879 AC Etten-Leur Nizozemska
English: 1105 BP Amsterdam Netherlands
Slovenian: 1105 BP Amsterdam Nizozemska
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: 93055 Regensburg Germany
Slovenian: 93055 Regensburg Nemčija
English: Table 6 Demographics and disease characteristics
Slovenian: Preglednica 6 Demografske značilnosti in značilnosti bolezni
English: No venous occlusive events were fatal.
Slovenian: Venski okluzivni dogodki niso bili smrtni.
English: Persistent grade 2 (longer than 7 days)
Slovenian: Perzistentna stopnja 2 (dlje kot 7 dni) Stopnja 3 ali višja stopnja
English: Baseline demographic characteristics are described in Table 6 below.
Slovenian: Izhodiščne demografske značilnosti so opisane spodaj v preglednici 6.
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: *ULN = Upper Limit of Normal for the lab
Slovenian: *ULN = zgornja meja normalnih vrednosti za laboratorij
English: Efficacy results are summarized in Table 7, Table 8, and Table 9.
Slovenian: Rezultati učinkovitosti so povzeti v preglednici 7, 8 in 9.
English: All patients (N=449)
Slovenian: Vsi bolniki (N = 449)
English: • recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Slovenian: • ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba jeter)
English: When adjusted for exposure, the incidence of first arterial occlusive events was greatest in the first two years of follow-up and declined with decreasing daily dose intensity (following recommendation for prospective dose reduction).
Slovenian: Ob prilagoditvi izpostavljenosti je bil pojav prvih arterijskih okluzivnih dogodkov največji v prvih dveh letih spremljanja in se je zmanjšal z zmanjšanjem jakosti dnevnega odmerka (po priporočilu za zmanjšanje prihodnjega odmerka).
English: Most patients who had an event of hepatotoxicity had their first event during the first year of treatment.
Slovenian: Pri večini bolnikov, pri katerih se je pojavila hepatotoksičnost, se je stanje prvič pojavilo v prvem letu zdravljenja.
English: Iclusig has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Iclusig ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Tell your doctor straight away if you experience any of these symptoms during your treatment with ponatinib, because it could be serious.
Slovenian: Nemudoma obvestite zdravnika, če se med zdravljenjem s ponatinibom pri vas pojavi kateri koli od teh simptomov, ker je stanje lahko resno.
English: See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.
Slovenian: Pred začetkom zdravljenja glejte poglavji 4.2 za oceno kardiovaskularnega statusa in 4.4 za situacije, v katerih je treba razmisliti o alternativnem zdravljenju.
English: If diagnosed, interrupt Iclusig treatment and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of PRES.
Slovenian: Če je diagnosticiran, prekinite zdravljenje z zdravilom Iclusig in z zdravljenjem nadaljujte šele, ko dogodek izzveni in če koristi nadaljnjega zdravljenja prevladajo nad tveganjem za PRES.
English: • if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section
Slovenian: • če ste alergični na ponatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • the number of white blood cells called neutrophils is reduced.
Slovenian: • se število belih krvnih celic, imenovanih nevtrofilci, zmanjša;
English: SPECIAL STORAGE CONDITIONS Store in the original container in order to protect from light.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalnem vsebniku za zagotovitev zaščite pred svetlobo.
English: Most of the patients with grade 3 or 4 platelet count decreased, anaemia or neutropenia, developed it within the first 3 months of treatment.
Slovenian: Pri večini bolnikov s 3. ali 4. stopnjo znižanega števila trombocitov, anemijo ali nevtropenijo, se je stanje razvilo v obdobju prvih 3 mesecev zdravljenja.
English: Table 11 shows these data for patients who achieved MCyR and MMR at 45 mg; similar data are available for patients who achieved MCyR and MMR at 30 mg.
Slovenian: V preglednici 11 so prikazani ti podatki za bolnike, ki so dosegli MCyR in MMR pri 45 mg; podobni podatki so na voljo za bolnike, ki so dosegli MCyR in MMR pri 30 mg.
English: Hepatic failure (including fatal outcome) has been observed.
Slovenian: Opazili so jetrno odpoved (vključno s smrtnim izidom).
English: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 93055 Regensburg Germany
Slovenian: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 93055 Regensburg Nemčija
English: * Spontaneous reports from post-marketing experience
Slovenian: * Spontana poročila po prihodu zdravila na trg
English: Before initiating Iclusig, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo zdravila Iclusig je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: Data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CPCML patients who underwent dose reduction for any reason.
Slovenian: Podatki iz preskušanja 2. faze so na voljo za vzdrževanje odgovora (MCyR in MMR) pri vseh bolnikih s CP-KML, pri katerih je bil odmerek zmanjšan zaradi katerega koli razloga.
English: Figure 1- Kaplan-Meier estimates for overall survival in the CP-CML population (Treated Population)
Slovenian: Slika 1 - Ocena po lestvici Kaplan-Meier za celokupno preživetje populacije bolnikov s CP-KML (zdravljene populacije)
English: Also, post-hoc analyses to assess the relationship of shorter-term cytogenetic (MCyR) and molecular (MMR) response outcomes with longer-term outcomes of PFS and OS, maintenance of response (MCyR and MMR) after dose reductions, and PFS and OS by Arterial Occlusive Event status were conducted.
Slovenian: Tudi post-hoc analize za oceno kratkoročnega citogenetskega (MCyR-major cytogenetic response) in molekularnega (MMR-major molecular response) odgovora z dolgoročnejšimi rezultati PFS in OS, vzdrževanje odgovora (MCyR in MMR) po zmanjšanju odmerka, in PFS ter OS so bile izvedene s statusom arterijskih okluzivnih dogodkov.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 1. julij 2013 Datum zadnjega podaljšanja: 8. februarja 2018
English: Of the CP-CML patients with no mutation detected at entry, 49% (66/136) achieved a MCyR.
Slovenian: Od bolnikov s CP-KML brez odkritij mutacij ob vstopu jih je 49 % (66/136) doseglo MCyR.
English: Additionally, after approximately 2 years of follow-up, all patients who were still taking a 45 mg daily dose were recommended to undergo a dose reduction, even in the absence of adverse events, in response to the continued occurrence of vascular occlusive events in the clinical trial.
Slovenian: Dodatno je bilo po približno 2 letih spremljanja vsem bolnikom, ki so prejemali dnevni odmerek 45 mg, priporočeno zmanjšanje odmerka, tudi če se neželeni učinki niso pojavili, kot odziv na nadaljevanje pojava vaskularnih okluzivnih dogodkov v kliničnem preskušanju.
English: Incyte Biosciences Distribution B.V. Paasheuvelweg 25
Slovenian: Incyte Biosciences Distribution B.V.
English: At the time of reporting, all ongoing patients had a minimum follow-up of 64 months.
Slovenian: V času poročanja so vse trenutne bolnike spremljali vsaj 64 mesecev.
English: Following a single oral dose of [14C]-labeled ponatinib, approximately 87% of the radioactive dose is recovered in the faeces and approximately 5% in the urine.
Slovenian: Po enkratnem peroralnem odmerku s [14C] označenega ponatiniba se je približno 87 % radioaktivnega odmerka pojavilo v blatu in približno 5 % v urinu.
English: Cytogenetic Response Major (MCyR) a
Slovenian: Citogenetski odgovor Bistven (MCyR) a
English: CP -CML patients who achieved MCyR or MMR response within the first year of treatment had statistically significantly improved progression-free (PFS) and overall survival (OS) compared to those patients who did not meet the treatment milestones.
Slovenian: Pri bolnikih s CP-KML, ki so dosegli MCyR ali MMR v prvem letu zdravljenja, se je statistično značilno izboljšalo stanje brez napredovanja bolezni (PFS) in celokupno preživetje (OS) v primerjavi z bolniki, ki niso dosegli mejnikov zdravljenja.
English: Age Median, years (range) Gender, n (%) Male Race, n (%) Asian Black/African American White Other ECOG Performance Status, n (%) ECOG=0 or 1 Disease history Median time from diagnosis to first dose, years (range) Resistant to Prior TKI Therapy a *, n (%)
Slovenian: Starost Mediana, leta (razpon) Spol, n (%) Moški Rasa, n (%) Azijci Črnci/afriški Američani Belci Drugo Status zmogljivosti po ECOG, n (%) ECOG = 0 ali 1 Zgodovina bolezni Mediana časa od diagnoze do prvega odmerka, leta (razpon) Odpornost na predhodno zdravljenje s TKIa*, n (%) Predhodno zdravljenje s TKI - število režimov, n (%)
English: For the overall CP-CML disease group, the probability of survival at 2, 3, 4, and 5 years is estimated as 86.0%, 81.2%, 76.9%, and 73.3%, respectively, as shown in Figure 1.
Slovenian: Za celotno skupino bolnikov s CP-KML je ocenjena verjetnost preživetja pri 2, 3, 4 in 5 letih 86,0 %, 81,2 %, 76,9 % in 73,3 %, kar je prikazano na sliki 1.
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥ 50% reduction of CRK-like (CRKL) phosphorylation, a biomarker of BCR-ABL inhibition, in peripheral blood mononuclear cells.
Slovenian: Pri odmerkih 15 mg ali več se je pri 32 od 34 bolnikov (94 %) pokazalo ≥ 50 % zmanjšanje fosforilacije encima CRK-like (CRKL), biomarkerja zaviranja BCR-ABL, v periferni krvi mononuklearnih celic.
English: Table 5 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥ 2% of patients in any disease group from the Phase 2 Trial (N=449): minimum follow-up of 64 month for all ongoing patients Laboratory test
Slovenian: stopnje* pri ≥ 2 % bolnikov v vsaki skupini bolezni iz preskušanja 2. faze (N=449): najmanj 64 mesecev spremljanja za vse bolnike Laboratorijski test
English: The anti-leukaemic activity of Iclusig was also evaluated in a phase 1 dose escalation study that included 65 CML and Ph+ ALL patients; the study is completed.
Slovenian: Protilevkemična aktivnost zdravila Iclusig je bila ocenjena tudi v študiji 1. faze s povečevanjem odmerka, v katero je bilo vključenih 65 bolnikov s KML in Ph+ ALL; študija je zaključena.
English: • The active substance is ponatinib.
Slovenian: • Učinkovina je ponatinib.
English: • blood clot in the main arteries carrying blood to the head or neck (carotid artery)
Slovenian: • krvni strdek v glavni arteriji, ki dovaja kri v glavo ali vrat (karotidna arterija)
English: 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).
Slovenian: Potencial zdravila Iclusig za podaljšanje intervala QT so ocenili pri 39 bolnikih z levkemijo, pri čemer niso opazili pomembnega podaljšanja intervala QT (glejte poglavje 5.1).
English: (95% CI) Major Molecular Response b
Slovenian: (95-% IZ) Bistven molekularni odgovor b
English: Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity studies.
Slovenian: Zdravilo Iclusig so ocenili v študijah farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja, fototoksičnosti in karcinogenosti.
English: • narrowing of the blood vessels, poor blood circulation, sudden increase in blood pressure
Slovenian: • zoženje krvnih žil, slab krvni obtok, nenadno zvišanje krvnega tlaka
English: In rats, treatment with ponatinib has shown effects on female fertility and male fertility was not affected (see section 5.3).
Slovenian: Pri podganah je zdravljenje s ponatinibom pokazalo učinke na plodnost pri samicah, pri samcih pa vpliva na plodnost ni bilo (glej poglavje 5.3).
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4%, neutropenia and anaemia < 1% each).
Slovenian: Ukinitev zdravljenja zaradi mielosupresije je bila redka (trombocitopenija 4 %, nevtropenija in anemija po < 1 %).
English: Hypertension may contribute to risk of arterial thrombotic events, including renal artery stenosis.
Slovenian: Hipertenzija lahko prispeva k tveganju arterijskih trombotičnih dogodkov, vključno s stenozo ledvične arterije.
English: • problems of the blood vessels in the heart muscle
Slovenian: • problemi s krvnimi žilami v srčni mišici
English: The European Medicines Agency has waived the obligation to submit the results of studies with Iclusig in children from birth to less than 1 year in CML and Ph+ ALL.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Iclusig za otroke od rojstva do 1. leta starosti s KML in Ph+ ALL.
English: b CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils < 5% in peripheral blood, No extramedullary involvement (including no hepatomegaly or splenomegaly).
Slovenian: b CHR: levkociti ≤ ULN ustanove, ANC ≥ 1.000/mm3, trombociti ≥ 100.000/mm3, brez blastov ali promielocitov v periferni krvi, blasti kostnega mozga ≤ 5 %, < 5 % mielociti plus metamielociti v periferni krvi, bazofilci < 5 % v periferni krvi, brez ekstramedularne vpletenosti (vključno brez hepatomegalije ali splenomegalije).
English: • uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) and chest pain not in connection with the heart
Slovenian: • nelagodno tiščanje, občutek polnosti, stiskanje ali bolečina v sredini prsnega koša (angina pektoris) in bolečina v prsih, ki ni povezana s srcem;
English: PRES is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances.
Slovenian: PRES je nevrološka motnja, ki jo lahko spremljajo znaki in simptomi, kot so epileptični napad, glavobol, zmanjšana pozornost, spremenjeno duševno delovanje, izguba vida ter druge motnje vida in nevrološke motnje.
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 64 months, the median durations of MCyR and MMR had not yet been reached.
Slovenian: V času posodobljenega poročanja z minimalnim spremljanjem za vse trenutne bolnike 64 mesecev mediano trajanje MCyR in MMR še ni bilo doseženo.
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE24
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE24
English: The most common serious adverse reactions >2% (treatment-emergent frequencies) were pneumonia (7.3%), pancreatitis (5.8%), abdominal pain (4.7%), atrial fibrillation (4.5%), pyrexia (4.5%), myocardial infarction (4.0%), peripheral arterial occlusive disease (3.8%), anaemia (3.8%), angina pectoris (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), hypertension (2.9%), coronary artery disease (2.7%), cardiac failure congestive (2.4%), cerebrovascular accident (2.4%), sepsis (2.4%), cellulitis (2.2%), acute kidney injury (2.0%), urinary tract infection (2.0%) and lipase increased (2.0%).
Slovenian: Najpogostejši resni neželeni učinki >2 % (pogostnosti v povezavi z zdravljenjem) so bili pljučnica (7,3 %), pankreatitis (5,8 %), bolečine v trebuhu (4,7 %), atrijska fibrilacija (4,5 %), pireksija (4,5%), miokardni infarkt (4,0 %), periferna arterijska okluzivna bolezen (3,8 %), anemija (3,8 %), angina pektoris (3,3 %), zmanjšanje števila trombocitov (3,1 %), febrilna nevtropenija (2,9 %), hipertenzija (2,9 %), bolezni koronarnih arterij (2,7 %), kongestivno srčno popuščanje (2,4 %), cerebrovaskularni dogodki (2,4 %), sepsa (2,4 %), celulitis (2,2 %), akutna poškodba ledvic (2,0 %), okužba urinarnega trakta (2,0 %) in zvišanje lipaze (2,0 %).
English: Gastrointestinal haemorrhage and subdural hematoma were the most commonly reported grade 3/4 bleeding events.
Slovenian: Gastrointestinalna krvavitev in subduralni hematom sta bili najpogosteje poročani krvavitvi 3./4.
English: Patients should be warned to immediately report suspected skin reactions, especially if associated with blistering, peeling, mucosal involvement or systemic symptoms.
Slovenian: Bolnike je treba opozoriti, da naj nemudoma poročajo o domnevnih neželenih učinkih na koži, zlasti če so povezani z mehurji, lupljenjem, poškodbami sluznice ali sistemskimi simptomi.
English: In the event of significant worsening, labile or treatment-resistant hypertension, treatment should be interrupted and evaluation for renal artery stenosis should be considered.
Slovenian: V primeru občutnega poslabšanja hipertenzije, labilne hipertenzije ali na zdravljenje odporne hipertenzije, je treba zdravljenje prekiniti in razmisliti o izvedbi ocene za stenozo ledvične arterije.
English: 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.
Slovenian: V predkliničnih študijah mutagenosti je bilo 40 nM določenih kot koncentracija ponatiniba, ki zadošča za zaviranje viabilnosti celic, ki izražajo vse testirane mutante BCR-ABL, za > 50 % (vključno s T315I) in zatrtje pojava mutiranih klonov.
English: The 0.8 mg/kg/day dose in females resulted in a plasma exposure level generally lower or equivalent to the human exposure at the range of dose from 15 mg to 45 mg daily.
Slovenian: Pri odmerku 0,8 mg/kg/dan pri samicah je bila raven plazemske izpostavljenosti na splošno manjša ali enaka izpostavljenosti pri ljudeh pri razponu odmerka od 15 mg do 45 mg na dan.
English: Management of toxicities
Slovenian: Obravnava toksičnosti
English: ≥ 12 month reduction at 30 mg 8 ≥ 18 month reduction at 30 mg 7 ≥ 24 month reduction at 30 mg 6 ≥ 36 month reduction at 30 mg 1 Any dose reduction to 15 mg ≥ 3 month reduction at 15 mg
Slovenian: ≥ 3 mesečno zmanjšanje pri 30 mg ≥ 6 mesečno zmanjšanje pri 30 mg ≥ 12 mesečno zmanjšanje pri 30 mg ≥ 18 mesečno zmanjšanje pri 30 mg ≥ 24 mesečno zmanjšanje pri 30 mg ≥ 36 mesečno zmanjšanje pri 30 mg Katero koli zmanjšanje odmerka na 15 mg ≥ 3 mesečno zmanjšanje pri 15 mg ≥ 6 mesečno zmanjšanje pri 15 mg ≥ 12 mesečno zmanjšanje pri 15 mg ≥ 18 mesečno zmanjšanje pri 15 mg ≥ 24 mesečno zmanjšanje pri 15 mg ≥ 36 mesečno zmanjšanje pri 15 mg
English: Ponatinib is highly bound (> 99%) to plasma proteins in vitro.
Slovenian: Ponatinib se in vitro močno veže (> 99 %) na beljakovine v plazmi.
English: Arterial occlusion
Slovenian: Arterijska okluzija
English: Overall arterial occlusive adverse reactions have occurred in 25% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 20% of patients.
Slovenian: Splošni arterijski okluzivni neželeni učinki so se pojavili pri 25 % bolnikov, zdravljenih z zdravilom Iclusig v preskušanju 2. faze, pri čemer so se resni neželeni učinki pojavili pri 20 % bolnikov.
English: Elevation of AST or ALT ≥ 3 × ULN concurrent with an elevation of bilirubin > 2 × ULN and alkaline phosphatase < 2 × ULN
Slovenian: Zvišanje AST ali ALT ≥ 3 x ULN in hkrati z zvišanjem bilirubina > 2 × ULN in alkalne fosfataze < 2 × ULN
English: The risk of arterial occlusive events is likely to be dose-related.
Slovenian: Tveganje arterijskih okluzivnih dogodkov je verjetno povezano z odmerkom.
English: The median time to onset of the first cardiovascular, cerebrovascular, and peripheral vascular arterial occlusive events was 351, 611, and 605 days, respectively.
Slovenian: Mediana časa do pojava prvih okluzivnih dogodkov srca in ožilja, cerebrovaskularnih in perifernih žilnih arterijskih okluzivnih dogodkov je bila 351, 611 oziroma 605 dni.
English: In a fertility study in male and female rats, female fertility parameters were reduced at dose levels corresponding to human clinical exposures.
Slovenian: V študiji plodnosti pri samcih in samicah podgan je bila plodnost pri samicah zmanjšana pri odmerkih, ki ustrezajo klinični izpostavljenosti pri ljudeh.
English: With a minimum follow-up of 48 months, and approximately 2 years after the recommendation for prospective dose reduction, there were 110 CP-CML patients ongoing.
Slovenian: Približno 2 leti po priporočilu za zmanjšanje prihodnjega odmerka in ob minimalnem spremljanju 48 mesecev, je bilo zdravljenih še 110 bolnikov s CP-KML.