FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects were shown to be reversible after withdrawal of the treatment.
Slovenian: Učinki so bili po prenehanju zdravljenja reverzibilni.
English: Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.
Slovenian: O mielosupresiji so poročali pri bolnikih z normalnimi izhodiščnimi laboratorijskimi vrednostmi, pa tudi pri bolnikih z obstoječimi laboratorijskimi nenormalnostmi.
English: * of 427 patients reporting prior TKI therapy with dasatinib or nilotinib
Slovenian: * od 427 bolnikov, ki so prejeli predhodno zdravljenje s TKI z dasatinibom ali nilotinibom
English: The analysis of the dose intensity-safety relationship in the phase 2 trial concluded that after adjusting for covariates, the overall dose intensity is significantly associated with an increased risk of vascular occlusion, with an odds ratio of approximately 1.6 for each 15 mg increase.
Slovenian: Analiza razmerja med intenzivnostjo odmerjanja in varnostjo v preskušanju 2. faze je pokazala, da je po prilagoditvi za sospremenljivke celokupna intenzivnost odmerjanja značilno povezana z večjim tveganjem za vaskularno okluzijo z razmerjem obetov približno 1,6 za vsakih 15 mg povečanja.
English: Recommendation for close monitoring of response if a dose reduction is undertaken.
Slovenian: Priporočilo za skrbno spremljanje odgovora ob zmanjšanju odmerka.
English: • metabolic disorders caused by the break-down products of dying cancer cells
Slovenian: • presnovna bolezen zaradi razgradnih produktov umirajočih rakavih celic
English: Patients with hepatic impairment may receive the recommended starting dose.
Slovenian: Bolniki z okvaro jeter lahko prejemajo priporočeni začetni odmerek.
English: Most patients who ultimately reduced dose to 15 mg initially had their dose reduced to 30 mg for a period.
Slovenian: Pri večini bolnikov, katerim je bil odmerek končno zmanjšan na 15 mg, je bil odmerek za nekaj časa zmanjšan na 30 mg.
English: • checks of the serum protein known as lipase A serum protein called lipase will be checked every 2 weeks for the first 2 months, then periodically.
Slovenian: • preveril serumsko beljakovino, znano kot lipaza Pregledi serumske beljakovine, imenovane lipaza, bodo prva 2 meseca opravljeni vsaka 2 tedna, nato pa občasno.
English: In the phase 2 trial, dose reductions were recommended following adverse events; in addition in October 2013 new recommendations for prospective dose reduction in all CP-CML patients in the absence of adverse events were introduced in this trial with the aim of reducing the risk of vascular occlusive events.
Slovenian: V preskušanju 2. faze so po neželenih učinkih priporočali zmanjšanje odmerka; poleg tega so oktobra 2013 v tem preskušanju uvedli nova priporočila za prospektivno zmanjšanje odmerka za vse bolnike s CP-KML brez neželenih učinkov, s ciljem zmanjšati tveganje vaskularnih okluzivnih dogodkov.
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Slovenian: Če se zdravilo uporablja med nosečnostjo, je treba bolnico obvestiti o možnem tveganju za plod.
English: • liver tests Liver function tests will be performed periodically, as indicated by your doctor.
Slovenian: • opravil jetrne teste Teste delovanja jeter vam bodo opravljali periodično po navodilih vašega zdravnika.
English: • the number of white blood cells called neutrophils is reduced.
Slovenian: • se število belih krvnih celic, imenovanih nevtrofilci, zmanjša
English: Preliminary data from the phase 2 trial are available on the maintenance of response (MCyR and MMR) in all CP-CML patients who underwent dose reduction for any reason.
Slovenian: Preliminarni 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: - alanine aminotransferase
Slovenian: - alanin-aminotransferaze
English: In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome.
Slovenian: Pri tej vrsti levkemije se je del DNK (genetski material) prerazporedil in oblikoval nenormalen kromosom, ki se imenuje kromosom Philadelphia.
English: Liver function tests should be performed prior to treatment initiation and monitored periodically, as clinically indicated.
Slovenian: Teste delovanja jeter je treba opraviti pred uvedbo zdravljenja in nato periodično, kot je klinično indicirano.
English: Make sure you take Iclusig daily for as long as it is prescribed.
Slovenian: Zdravilo Iclusig morate jemati vsak dan, dokler je predpisano.
English: Table 10 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 10 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: 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*, n (%) Prior TKI therapy- number of regimens, 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 TKI*, n (%) Predhodno zdravljenje s TKI - število režimov, n (%)
English: Formal studies of ponatinib with anti-clotting medicinal products have not been conducted.
Slovenian: Formalnih študij s ponatinibom in zdravili proti strjevanju krvi niso opravili.
English: The risk of vascular occlusive events is likely to be dose-related.
Slovenian: Tveganje žilnih okluzivnih dogodkov je verjetno povezano z odmerkom.
English: Before starting treatment with ponatinib, the cardiovascular status of the patient should be assessed, including history and physical examination, and cardiovascular risk factors should be actively managed.
Slovenian: Pred začetkom zdravljenja s ponatinibom je treba oceniti kardiovaskularni status bolnika, vključno z anamnezo in telesnim pregledom, in aktivno obravnavati kardiovaskularne dejavnike tveganja.
English: All patients received 45 mg Iclusig once daily.
Slovenian: Vsi bolniki so prejemali 45 mg zdravila Iclusig enkrat na dan.
English: • nerve disorder in the arms and/or legs (often causes numbness and pain in the hands and feet)
Slovenian: • bolezni živcev v rokah in/ali nogah (pogosto povzročijo omrtvelost in bolečine dlani in stopal)
English: Important adverse reactions
Slovenian: Pomembne neželene reakcije
English: The blood/plasma ratio of ponatinib is 0.96.
Slovenian: Razmerje ponatiniba v krvi/plazmi je 0,96.
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 27 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 27 mesecev mediano trajanje MCyR in MMR še ni bilo doseženo.
English: Renal excretion is not a major route of ponatinib elimination.
Slovenian: Izločanje skozi ledvice ni glavna pot izločanja ponatiniba.
English: 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.
Slovenian: Ponatinib zavira aktivnost drugih klinično pomembnih kinaz z vrednostmi IC50 pod 20 nM in je pokazal celično aktivnost proti RET, FLT3 in KIT ter članom družin kinaz FGFR, PDGFR in VEGFR.
English: For every BCR-ABL mutation detected in more than one CP-CML patient at entry, a MCyR was achieved following treatment with Iclusig.
Slovenian: Za vsako mutacijo BCR-ABL, odkrito pri več kot enem bolniku s CP-KML ob vstopu, je bil po zdravljenju z zdravilom Iclusig dosežen MCyR.
English: In addition, the pharmacokinetic-pharmacodynamic models show no exposure-effect relationship, with an estimated QTcF mean change of -6.4 ms (upper confidence interval -0.9 ms) at Cmax for the 60 mg group.
Slovenian: Poleg tega farmakokinetični-farmakodinamični modeli ne kažejo na povezavo med izpostavljenostjo in učinkom, z ocenjeno povprečno spremembo QTcF za -6,4 ms (zgornji interval zaupanja -0,9 ms) pri Cmax za skupino, ki je prejemala 60 mg.
English: Neutropenia (ANC decreased)
Slovenian: Nevtropenija (zmanjšanje ANC)
English: • uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris)
Slovenian: • nelagodno tiščanje, občutek polnosti, stiskanje ali bolečina v sredini prsnega koša (angina pektoris)
English: In order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reductions after achieving MCyR in patients with CP-CML, the MAH should conduct and submit the results of a doseranging study.
Slovenian: Za določitev optimalnega začetnega odmerka zdravila Iclusig in karakterizacijo varnosti in učinkovitosti zdravila Iclusig po zmanjšanju odmerka po doseženem MCyR pri bolnikih s CP-KML, bo imetnik dovoljenja za promet z zdravilom izvedel in predložil rezultate študije o razponu odmerka.
English: Other medicines and Iclusig
Slovenian: Druga zdravila in zdravilo Iclusig
English: An integrated population pharmacokinetic analysis completed for ponatinib suggests that age may be predictive of variability for ponatinib apparent oral clearance (CL/F).
Slovenian: Integrirana analiza populacijske farmakokinetike, opravljena za ponatinib, kaže, da starost lahko napoveduje spremenljivost navideznega peroralnega očistka ponatiniba (CL/F).
English: • breathing difficulties
Slovenian: • težave z dihanjem
English: • chest pain not in connection with the heart
Slovenian: • bolečine v prsnem košu, ki niso povezane s srcem
English: 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%).
Slovenian: Skupaj je imelo 55 % bolnikov eno ali več mutacij domene kinaze BCR-ABL ob vstopu, pri čemer so bile najpogostejše: T315I (29 %), F317L (8 %), E255K (4 %) in E359V (4 %).
English: • pravastatin, rosuvastatin: medicines to lower elevated cholesterol levels.
Slovenian: • pravastatin, rosuvastatin: zdravila za zniževanje zvišanih ravni holesterola
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: Možnost za podaljšanje intervala QT zdravila Iclusig so ocenili pri 39 bolnikih z levkemijo, pri čemer niso opazili pomembnega podaljšanja intervala QT (glejte poglavje 5.1).
English: Iclusig should be used during pregnancy only when clearly necessary.
Slovenian: Zdravilo Iclusig je dovoljeno med nosečnostjo uporabljati le, če je to nujno potrebno.
English: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Germany
Slovenian: Haupt Pharma - AMAREG GmbH Donaustaufer Strasse 378 D-93055 Regensburg Nemčija
English: Maintained MCyR
Slovenian: Vzdrževan MCyR
English: The Marketing Authorisation Holder shall ensure that in each Member State where ICLUSIG is marketed all physicians who are expected to prescribe ICLUSIG are provided with the Healthcare Professional
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo v vsaki državi članici, v kateri se trži zdravilo ICLUSIG, vsi zdravniki, za katere se pričakuje, da bodo zdravilo ICLUSIG predpisovali,
English: Do not take Iclusig • if you are allergic to ponatinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na ponatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • carbamazepine: a medicine to treat epilepsy, euphoric/depressive stages and certain pain conditions.
Slovenian: • karbamazepin: zdravilo za zdravljenje epilepsije, evforičnih/depresivnih faz in določenih bolečin
English: Compared to healthy volunteers with normal liver function, no major differences in ponatinib PK were observed in patients with varying degrees of hepatic impairment.
Slovenian: V primerjavi z zdravimi prostovoljci z normalnim delovanjem jeter niso opazili bistvenih razlik v FK ponatiniba pri bolnikih z različnimi stopnjami okvare jeter.
English: Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Slovenian: Preglednica 2 Prilagajanje odmerka pri pankreatitisu in zvišani ravni lipaze/amilaze Pankreatitis 2. stopnje in/ali asimptomatsko zvišanje ravni lipaze/amilaze
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 ongoing.
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 še poteka.
English: At doses of 15 mg or greater, 32 of 34 patients (94%) demonstrated a ≥50% reduction of 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 CRKL, biomarkerja zaviranja BCR-ABL, v periferni krvi mononuklearnih celic.
English: Although plasma ponatinib exposures increased to steady-state levels with continuous dosing, a population pharmacokinetic analysis predicts a limited increase in apparent oral clearance within the first two weeks of continuous dosing, which is not considered clinically relevant.
Slovenian: Čeprav se s stalnim odmerjanjem izpostavljenost ponatinibu v plazmi povečuje do ravni dinamičnega ravnovesja, analiza populacijske farmakokinetike napoveduje omejeno povečanje navideznega peroralnega očistka v prvih dveh tednih stalnega odmerjanja, vendar se to ne smatra kot klinično pomembno.
English: Ponatinib is metabolized by CYP3A4.
Slovenian: Ponatinib se presnavlja z encimom CYP3A4.
English: 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).
Slovenian: Zdravila Iclusig se ne sme uporabljati pri bolnikih z miokardnim infarktom, predhodno revaskularizacijo ali možgansko kapjo v anamnezi, razen če so možne koristi zdravljenja večje od možnih tveganj (glejte poglavji 4.2 in 4.8).
English: Iclusig is used to treat adults with the following leukaemia types who are no longer benefiting from treatment with other medicines, or have a certain genetic difference known as a T315I mutation:
Slovenian: Zdravilo se uporablja za zdravljenje odraslih bolnikov z naslednjimi tipi levkemije, ki jim zdravljenje z drugimi zdravili ne pomaga več, ali ki imajo posebno gensko spremembo, znano kot mutacija T315I:
English: Multiple doses of 90 mg per day for 12 days in a patient resulted in pneumonia, systemic inflammatory response, atrial fibrillation, and asymptomatic, moderate pericardial effusion.
Slovenian: Večkratni odmerki po 90 mg na dan v obdobju 12 dni so pri bolnikih povzročili pljučnico, sistemski vnetni odziv, atrijsko fibrilacijo in asimptomatski, zmerni perikardni izliv.
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: • rifabutin, rifampicin: medicines to treat tuberculosis or certain other infections.
Slovenian: • rifabutin, rifampicin: zdravili za zdravljenje tuberkuloze ali nekaterih drugih okužb
English: Pancreatitis Recommended modifications for pancreatic adverse reactions are summarized in Table 2.
Slovenian: Priporočeno prilagajanje pri neželenih reakcijah, povezanih s trebušno slinavko, je povzeto v preglednici 2.
English: Iclusig is indicated in adult patients with
Slovenian: Zdravilo Iclusig je indicirano pri odraslih bolnikih
English: Check serum lipase every 2 weeks for the first 2 months and then periodically thereafter.
Slovenian: Prva 2 meseca vsaka 2 tedna preverjajte serumsko lipazo, nato pa periodično.
English: INFORMATION IN BRAILLE Outer Carton:
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina:
English: 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.
Slovenian: Dejavniki, ki jih je treba upoštevati pri zmanjšanju odmerka bolnikom s CPKML, ki so dosegli MCyR, v odsotnosti neželenega učinka.
English: Cardiovascular status should continue to be monitored and medical and supportive therapy for conditions that contribute to cardiovascular risk should be optimised during treatment with ponatinib.
Slovenian: Kardiovaskularni status je treba še naprej spremljati in med zdravljenjem s ponatinibom optimizirati zdravljenje z zdravili in podporno zdravljenje stanj, ki prispevajo h kardiovaskularnim tveganjem.
English: Following either a high-fat and low-fat meal, plasma ponatinib exposures (Cmax and AUC) were not different versus fasting conditions.
Slovenian: Po obroku z visoko ali nizko vsebnostjo maščob se plazemske izpostavljenosti ponatiniba (Cmax in AUC) niso razlikovale od tistih na tešče.
English: Iclusig is associated with pancreatitis.
Slovenian: Zdravilo Iclusig je povezano s pankreatitisom.
English: b CHR: WBC ≤ institutional ULN, ANC ≥1000/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: • rash, dry skin
Slovenian: • izpuščaj, suha koža
English: BP-CML/Ph+ ALL (N=94)
Slovenian: BP-KML/Ph+ ALL (N = 94)
English: Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, and phototoxicity studies.
Slovenian: Zdravilo Iclusig so ocenili v študijah farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja in fototoksičnosti.
English: Anaemia (Hgb decreased)
Slovenian: Anemija (znižana raven Hgb)
English: Iclusig belongs to a group of medicines called tyrosine kinase inhibitors.
Slovenian: Zdravilo Iclusig sodi v skupino zdravil, imenovanih zaviralci tirozin-kinaze.
English: Vascular occlusion (see section 4.2 and 4.4).
Slovenian: Žilna okluzija (glejte poglavji 4.2 in 4.4)
English: Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
Slovenian: Terapijo mora uvesti zdravnik z izkušnjami v diagnosticiranju in zdravljenju bolnikov z levkemijo.
English: • Recommendation to consider discontinuing ponatinib if a complete haematologic response has not occurred by 3 months (90 days).
Slovenian: • Priporočila, da je treba razmisliti o ukinitvi ponatiniba, če v 3 mesecih (90 dneh) ni celovitega hematološkega odgovora.
English: 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.
Slovenian: Prejšnji ali boljši MCyR (MCyR, MMR ali CMR) na dasatinib ali nilotinib je bil dosežen pri le 26 % bolnikov s CP-KML in prejšnji ali boljši MaHR (MaHR, MCyR, MMR ali CMR) je bil dosežen pri le 21 % bolnikov z AP-KML in 24 % z BP-KML/Ph+ALL.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redkimi dednimi težavami neprenašanja galaktoze, laponsko obliko zmanjšane aktivnosti laktaze ali slabo absorpcijo glukoze-galaktoze ne smejo jemati tega zdravila.
English: Therefore, clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of substrates for these transporters.
Slovenian: Zato ni verjetno, da bi se pojavilo klinično medsebojno delovanje med zdravili kot posledica zaviranja substratov teh prenašalcev, pri katerem posreduje ponatinib.
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: Compared to patients < 65 years, older patients are more likely to experience adverse reactions.
Slovenian: V primerjavi z bolniki, starimi < 65 let, je verjetnost neželenih učinkov pri starejših bolnikih večja.
English: Patients should not crush or dissolve the tablets.
Slovenian: Bolniki tablet ne smejo drobiti ali raztapljati.
English: Dose adjustments to 30 mg once daily or 15 mg once daily were allowed for the management of treatment toxicity.
Slovenian: Prilagoditev odmerka na 30 mg enkrat na dan ali 15 mg enkrat na dan je bila dovoljena v primeru obravnave toksičnosti zaradi zdravljenja.
English: If a dose reduction is considered, the following factors should be to taken into account in the individual benefit-risk assessment: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels (see sections 4.4 and 5.1).
Slovenian: Če se razmišlja o zmanjšanju odmerka, je treba pri oceni koristi in tveganj za posameznika upoštevati naslednje dejavnike: kardiovaskularno tveganje, neželene učinke zdravljenja s ponatinibom, čas do citogenetskega odgovora in ravni transkriptov BCR-ABL (glejte poglavji 4.4 in 5.1).
English: 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.
Slovenian: Študije in vitro kažejo, da ponatinib ni substrat ali da je šibek substrat tako za P-gp in za beljakovino rezistence za raka dojke, BCRP.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE24
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE24
English: OTHER SPECIAL WARNING(S), IF NECESSARY Outer Carton:
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zunanja ovojnina:
English: Most haemorrhagic events, but not all, occurred in patients with grade 3/4 thrombocytopenia.
Slovenian: Največ krvavitev, vendar ne vse, se je pojavilo pri bolnikih s trombocitopenijo 3./4.
English: Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled.
Slovenian: Zdravljenje z zdravilom Iclusig je treba začasno prekiniti, če hipertenzija ni pod zdravniškim nadzorom.
English: Discontinue Iclusig *IULN = institution upper limit of normal
Slovenian: Ukinite zdravljenje z zdravilom Iclusig *IULN = zgornja meja normalnih vrednosti, specifična za ustanovo (institutional upper limit of normal)
English: Ponatinib is highly bound (>99%) to plasma proteins in vitro.
Slovenian: Ponatinib se in vitro močno veže (> 99 %) na beljakovine v plazmi.