FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3 or 4 asymptomatic elevation of lipase/amylase (> 2.0 x IULN*) only
Slovenian: Samo asimptomatsko zvišanje ravni lipaze/amilaze 3. ali 4. stopnje (> 2,0 x IULN*)
English: Cerebral haemorrhage and gastrointestinal haemorrhage were the most commonly reported serious bleeding events.
Slovenian: Cerebralna krvavitev in gastrointestinalna krvavitev sta bili najpogosteje poročani resni krvavitvi.
English: Effective contraception must be used during treatment.
Slovenian: Med zdravljenjem morate uporabljati učinkovito kontracepcijo.
English: The carboxylic acid and the N-desmethyl metabolite comprise 58% and 2% of the circulating levels of ponatinib, respectively.
Slovenian: Karboksilna kislina in presnovek N-desmetil predstavljata 58 % oz. 2 % ravni ponatiniba v obtoku.
English: Table 1 Dose modifications for myelosuppression
Slovenian: Preglednica 1 Prilagajanje odmerka zaradi mielosupresije
English: • a history of alcohol abuse
Slovenian: • zlorabo alkohola v zdravstveni zgodovini
English: If you stop taking Iclusig
Slovenian: Če ste prenehali jemati zdravilo Iclusig
English: In a cell-based accelerated mutagenesis assay, no mutation in BCR-ABL was detected that could confer resistance to 40 nM ponatinib.
Slovenian: V pospešenem celičnem testu mutagenosti niso opazili mutacij BCR-ABL, ki bi lahko povzročile odpornost na 40 nM ponatiniba.
English: 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.
Slovenian: Geometrično povprečje (CV %) Cmax in AUC(0-τ) izpostavljenosti, doseženo za ponatinib 45 mg na dan v stanju dinamičnega ravnovesja, je bilo 77 ng/ml (50 %) oz. 1296 ng•hr/ml (48 %).
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: An effective method of contraception should be used during treatment.
Slovenian: Med zdravljenjem je treba uporabljati učinkovito metodo kontracepcije.
English: Iclusig use may be resumed at the same, or a reduced dose, after the event is resolved or controlled.
Slovenian: Z jemanjem zdravila Iclusig lahko ponovno začnete z istim ali zmanjšanim odmerkom, ko dogodek izzveni ali je pod nadzorom.
English: ALT=alanine aminotransferase, ANC=absolute neutrophil count, AST=aspartate aminotransferase, Hgb=haemoglobin, WBC=white blood cell count.
Slovenian: ALT = alanin aminotransferaza, ANC = absolutno število nevtrofilcev, AST = aspartat aminotransferaza, Hgb = hemoglobin.
English: At the time of reporting, 25 CP-CML patients were in MCyR (median duration of MCyR had not been reached).
Slovenian: V času poročanja je imelo MCyR 25 bolnikov s CP-KML (mediana trajanja MCyR ni bila dosežena).
English: PHARMACEUTICAL FORM AND CONTENTS 60 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 60 tablet
English: In 67% of CP-CML patients in the R/I cohort, no mutations were detected at study entry.
Slovenian: Pri 67 % bolnikov s CP-KML v kohorti O/N ob vstopu v študijo niso odkrili mutacij.
English: Haematological Response Rate Majora (MaHR)
Slovenian: Stopnja hematološkega odgovora Bistvena (MaHR)
English: Peak concentrations of ponatinib are observed approximately 4 hours after oral administration.
Slovenian: Najvišje koncentracije ponatiniba so opazili približno 4 ure po peroralni uporabi.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Iclusig in paediatric patients from 1 year to less than 18 years in CML and Ph+ ALL (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Iclusig za pediatrične bolnike od 1 leta do 18 leta starosti s KML in Ph+ ALL (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Slovenian: c MCyR združuje celovite (brez zaznavnih celic Ph+) in delne (1 % do 35 % celic Ph+) citogenetske odgovore.
English: A proportion of patients did not undergo any dose reduction, based on an individual benefit-risk assessment.
Slovenian: Pri delu bolnikov se odmerek na podlagi individualne ocene koristi in tveganj ni zmanjšal.
English: 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).
Slovenian: Čeprav izločanje skozi ledvice ni glavna pot izločanja ponatiniba, možnosti vpliva zmerne ali hude okvare ledvic na izločanje skozi jetra niso ugotavljali (glejte poglavje 4.2).
English: Of the CP-CML patients with no mutation detected at entry, 46% (63/136) achieved a MCyR.
Slovenian: Od bolnikov s CP-KML brez odkritij mutacij ob vstopu jih je 46 % (63/136) doseglo MCyR.
English: Most of these events occurred at the dose at which the patient achieved MCyR; fewer events occurred after dose reduction.
Slovenian: Večina teh neželenih učinkov se je pojavila pri odmerku, ob katerem je bolnik dosegel MCyR; dogodki z zvišano telesno temperaturo so se pojavili po zmanjšanju odmerka.
English: • increased blood levels of several liver enzymes called:
Slovenian: • zvišane ravni različnih jetrnih encimov v krvi, imenovanih:
English: 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.
Slovenian: Vsi bolniki so dobivali 45 mg zdravila Iclusig enkrat na dan z možnostjo zmanjševanja odmerka in prekinitvijo odmerjanja, ki ji je sledila ponovna uvedba odmerjanja in povečevanje odmerka.
English: Discontinuation due to myelosuppression was infrequent (thrombocytopenia 4.5%, neutropenia and anaemia <1% each).
Slovenian: Ukinitev zdravljenja zaradi mielosupresije je bila redka (trombocitopenija 4,5 %, nevtropenija in anemija po < 1 %).
English: CP-CML (N=270)
Slovenian: CP-KML (N = 270)
English: Patients with estimated creatinine clearance of ≥ 50 mL/min should be able to safely receive Iclusig with no dosage adjustment.
Slovenian: Bolniki z ocenjenim očistkom kreatinina ≥ 50 ml/min lahko varno dobivajo zdravilo Iclusig brez prilagajanja odmerka.
English: - aspartate aminotransferase
Slovenian: - aspartat-aminotransferaze
English: • low calcium, phosphate or potassium levels in the blood
Slovenian: • nizke ravni kalcija, fosfata ali kalija v krvi
English: • dabigatran: a medicine to prevent the formation of blood clots.
Slovenian: • dabigatran: zdravilo za preprečevanje nastajanja krvnih strdkov
English: See the package leaflet for further information.
Slovenian: Za več informacij preberite priloženo navodilo.
English: The most common serious adverse reactions >1% (treatment-emergent frequencies) were pancreatitis (5.6%), pyrexia (4.2%), abdominal pain (4.0%), myocardial infarction (3.6%), atrial fibrillation (3.3%), anaemia, (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), cardiac failure (2.0%), lipase increased (1.8%), dyspnea (1.6%), diarrhoea (1.6%), neutrophil count decreased (1.3%), pancytopenia (1.3%), and pericardial effusion (1.3%).
Slovenian: Najpogostejši resni neželeni učinki >1 % (pogostnosti v povezavi z zdravljenjem) so bili pankreatitis (5,6 %), pireksija (4,2 %), bolečine v trebuhu (4,0 %), miokardni infarkt (3,6 %), atrijska fibrilacija (3,3 %), anemija (3,3 %), znižanje števila trombocitov (3,1 %), febrilna nevtropenija (2,9 %), srčno popuščanje (2,0 %), zvišanje lipaze (1,8 %), dispneja (1,6 %), driska (1,6 %), znižanje števila nevtrofilcev (1,3 %), pancitopenija (1,3 %) in perikardni izliv (1,3 %).
English: Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events.
Slovenian: Dogodki so se pojavili pri bolnikih z dejavniki kardiovaskularnega tveganja in brez njih, vključno z bolniki, starimi 50 let ali manj.
English: • The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 3000, polyvinyl alcohol, titanium dioxide (E171).
Slovenian: • Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, natrijev karboksimetilškrob, (koloidni brezvodni) silicijev dioksid, magnezijev stearat, smukec, makrogol 4000, polivinilalkohol, titanov dioksid (E171).
English: Therefore, ponatinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) or BCRP (e.g., methotrexate, rosuvastatin, sulfasalazine) and may increase their therapeutic effect and adverse reactions.
Slovenian: Zato lahko ponatinib zviša koncentracije sočasno uporabljenih substratov P-gp (npr. digoksin, dabigatran, kolhicin, pravastatin) ali BCRP (npr. metotreksat, rosuvastatin, sulfasalazin) v plazmi in poveča njihov terapevtski učinek in neželene učinke.
English: In juvenile rats, mortality related to inflammatory effects was observed in animals treated with 3 mg/kg/day, and reductions in body weight gain were observed at doses of 0.75, 1.5 and 3 mg/kg/day during the pre weaning and early post weaning treatment phases.
Slovenian: Pri juvenilnih podganah so pri živalih, ki so dobivale 3 mg/kg/dan, opazili smrtnost, povezano z vnetnimi učinki, in zmanjšanje pridobivanja telesne mase pri odmerkih 0,75, 1,5 in 3 mg/kg/dan v obdobju zdravljenja pred odstavitvijo in v zgodnjem obdobju po odstavitvi.
English: • nefazodone: a medicine to treat depression.
Slovenian: • nefazodon: zdravilo za zdravljenje depresije
English: Overall, the most common adverse reactions (≥20%) were platelet count decreased, rash, dry skin, and abdominal pain.
Slovenian: Na splošno so bili najpogostejši neželeni učinki (≥ 20 %) zmanjšanje števila trombocitov, izpuščaj, suha koža in bolečine v trebuhu.
English: If you forget to take Iclusig
Slovenian: Če ste pozabili vzeti zdravilo Iclusig
English: 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).
Slovenian: Opredeljeno kot ≤ 0,1 % razmerje BCR-ABL glede na transkripte ABL na mednarodni lestvici (IS, International Scale) (tj. ≤ 0,1 % BCR-ABLIS; bolniki morajo imeti transkript b2a2/b3a2 (p210)), v periferni krvi, izmerjeno s pomočjo kvantitativne reakcije verižne polimerizacije reverzne transkriptaze (qRT PCR, quantitative reverse transcriptase polymerase chain reaction).
English: 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.
Slovenian: V dnevnih odmerkih 45 mg je geometrično povprečje (CV %) navideznega volumna porazdelitve v stanju dinamičnega ravnovesja 1101 l (94 %), kar kaže na to, da se ponatinib izčrpno porazdeli v ekstravaskularnem prostoru.
English: Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig.
Slovenian: Bolnike je treba spremljati za znake ali simptome, ki kažejo na srčno popuščanje, in jih zdraviti, kot je klinično ustrezno, vključno s prekinitvijo zdravljenja z zdravilom Iclusig.
English: • heart problems, including heart failure, irregular heartbeats, and QT prolongation
Slovenian: • težave s srcem, vključno s srčnim popuščanjem, nerednim srčnim utripom in podaljšanim intervalom QT
English: 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.
Slovenian: V preskušanju 2. faze je 87 bolnikov s CP-KML doseglo MCyR pri odmerku 45 mg, 45 bolnikov s CP-KML je doseglo MCyR po zmanjšanju odmerka na 30 mg, največkrat zaradi neželenih učinkov.
English: • Information on important adverse reactions for which monitoring and/or dose adjustment are recommended as outlined in the SmPC: pancreatitis, increased amylase and lipase levels, myelosuppression, liver function test abnormalities, haemorrhage, cardiac failure/left ventricular dysfunction, vascular occlusive events and hypertension.
Slovenian: • Informacije o pomembnih neželenih učinkih, za katere se priporoča spremljanje in/ali prilagajanje odmerka, kot je opisano v povzetku glavnih značilnosti zdravila: pankreatitis, povečane ravni amilaze in lipaze, mielosuppresija, nenormalnosti testa delovanja jeter, krvavitev, odpoved srca/disfunkcija levega prekata, vaskularni okluzivni dogodki in hipertenzija.
English: • increased or reduced sense of touch or sensation, abnormal sensation such as prickling, tingling and itchiness
Slovenian: • povečana ali zmanjšana občutljivost za dotik ali občutek, nenormalni občutki, kot so ščemenje,
English: What Iclusig is and what it is used for What you need to know before you take Iclusig How to take Iclusig
Slovenian: Kaj je zdravilo Iclusig in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Iclusig Kako jemati zdravilo Iclusig Možni neželeni učinki
English: A reduction of the starting dose of Iclusig in patients with hepatic impairment is not necessary (see sections 4.2 and 4.4).
Slovenian: Zmanjšanje začetnega odmerka zdravila Iclusig pri bolnikih z okvaro jeter ni potrebno (glejte poglavji 4.2 in 4.4).
English: Do not crush or dissolve the tablets.
Slovenian: Tablet ne drobite in ne raztapljajte.
English: The median duration of treatment with Iclusig was 866 days in CP-CML patients, 590 days in AP-CML patients, and 86 days in BP-CML/Ph+ ALL patients.
Slovenian: Mediana trajanja zdravljenja z zdravilom Iclusig je bila 866 dni pri bolnikih s CP-KML, 590 dni pri bolnikih z AP-KML in 86 dni pri bolnikih z BP-KML/Ph+ ALL.
English: Riverbridge House Guildford Road
Slovenian: Guildford Road
English: The risk of vascular occlusive events is likely to be dose-related (see sections 4.2 and 5.1).
Slovenian: Tveganje žilnih okluzivnih dogodkov je verjetno povezano z odmerkom (glejte poglavji 4.2 in 5.1).
English: • 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).
Slovenian: • kronična mieloična levkemija (KML): krvni rak, ki vključuje preveliko število nenormalnih belih krvnih celic v krvi in kostnem mozgu (kjer nastajajo krvne celice).
English: Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 1.
Slovenian: Prilagajanje odmerka v primeru nevtropenije (ANC* < 1,0 x 109/l) ali trombocitopenije (trombociti < 50 x 109/l), ki nista povezani z levkemijo, je povzeto v preglednici 1.
English: - alkaline phosphatase
Slovenian: - alkalne fosfataze
English: ANC* < 1.0 x 109/L or platelet < 50 x 109/L
Slovenian: ANC* < 1,0 x 109/l ali trombociti < 50 x 109/l
English: Myelosuppression was generally reversible and usually managed by withholding Iclusig temporarily or reducing the dose (see section 4.2).
Slovenian: Mielosupresija je bila načeloma reverzibilna in so jo obvladali z začasnim prenehanjem uporabe zdravila Iclusig ali zmanjšanjem odmerka (glejte poglavje 4.2).
English: 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.
Slovenian: Neželene učinke, opisane v tem poglavju, so opredelili v odprtem, mednarodnem, multicentričnem preskušanju z eno skupino s 449 bolniki s KML in Ph+ ALL, ki se na predhodno zdravljenje s TKI niso odzivali ali ga niso prenašali, vključno s tistimi z mutacijo BCR-ABL T315I.
English: Women of childbearing potential/Contraception in males and females Women of childbearing age being treated with Iclusig should be advised not to become pregnant and men being treated with Iclusig should be advised not to father a child during treatment.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženskam v rodni dobi, ki se zdravijo z zdravilom Iclusig, je treba svetovati, da naj v času zdravljenja z zdravilom Iclusig ne zanosijo, moškim pa, da naj v času zdravljenja z zdravilom Iclusig ne zaplodijo otroka.
English: 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).
Slovenian: Za formalna priporočila glede spreminjanja odmerkov v odsotnosti neželenega dogodka, kot strategijo za zmanjšanje tveganj, je potrebnih več podatkov o vzdrževanju odgovora (glejte poglavji 4.2 in 4.4).
English: Patients aged 65 and over are more likely to be affected by side effects.
Slovenian: Pri bolnikih, starih 65 let in več, je bolj verjetno, da se bodo pojavili neželeni učinki.
English: Following single and multiple 45 mg doses of Iclusig, the terminal elimination half-life of ponatinib was 22 hours, and steady state conditions are typically achieved within 1 week of continuous dosing.
Slovenian: Po enkratnem in večkratnih odmerkih 45 mg zdravila Iclusig je bil končni razpolovni čas ponatiniba 22 ur, stanje dinamičnega ravnovesja pa je bilo običajno doseženo v 1 tednu od začetka stalnega odmerjanja.
English: Pancreatitis and serum lipase
Slovenian: Pankreatitis in serumska lipaza
English: The recommended starting dose is one 45 mg film-coated tablet once daily.
Slovenian: Priporočeni začetni odmerek je ena 45 mg filmsko obložena tableta enkrat na dan.
English: Iclusig treatment should be temporarily interrupted if hypertension is not medically controlled (see section 4.2).
Slovenian: Zdravljenje z zdravilom Iclusig je treba začasno prekiniti, če hipertenzija ni pod zdravniškim nadzorom (glejte poglavje 4.2).
English: Overall (N=83)
Slovenian: Skupaj (N = 83)
English: You should take special care when driving and using machines as patients taking Iclusig may experience visual disturbance, dizziness, sleepiness, and tiredness.
Slovenian: Pri vožnji ali upravljanju strojev bodite posebno pozorni, saj se lahko pri bolnikih, ki jemljejo zdravilo Iclusig, pojavijo motnje vida, omotica, zaspanost in utrujenost.
English: 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.
Slovenian: Sočasni uporabi močnih induktorjev CYP3A4, kot so karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin in šentjanževka s ponatinibom se je treba izogniti in poiskati alternative induktorju CYP3A4, razen če so koristi večje od možnega tveganja za premajhno izpostavljenost ponatinibu.
English: Occurrence at 45 mg:
Slovenian: Pojav pri 45 mg:
English: 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.
Slovenian: Bolnike so dodelili v eno od šestih kohort na podlagi faze bolezni (CP-KML; AP-KML ali BP-KML/Ph+ ALL), odpornost ali neprenašanje (O/N) dasatiniba ali nilotiniba in prisotnost mutacije T315I.
English: • digoxin: a medicine to treat heart weakness.
Slovenian: • digoksin: zdravilo za zdravljenje šibkega srca
English: Overall (N=62)
Slovenian: Skupaj (N = 62)
English: - increased levels of the serum proteins lipase or amylase.
Slovenian: - zvišane ravni serumskih beljakovin lipaze ali amilaze
English: • liver damage, jaundice (symptoms include: yellowing of the skin and eyes)
Slovenian: • poškodba jeter, zlatenica (simptomi vključujejo: porumenelost kože in oči)
English: • stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations)
Slovenian: • možganska kap (simptomi vključujejo težave z govorom ali premikanjem, zaspanost, migreno, nenormalne občutke)
English: 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-∞.
Slovenian: Sočasna uporaba zdravila Iclusig z močnimi zaviralci izločanja želodčne kisline je povzročila manjše zmanjšanje Cmax ponatiniba in nobenega zmanjšanja AUC0-∞.
English: This medicinal product contains lactose monohydrate.
Slovenian: To zdravilo vsebuje laktozo monohidrat.
English: 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.
Slovenian: Varnost in učinkovitost zdravila Iclusig pri bolnikih s KML in Ph+ ALL, ki so bili na predhodno zdravljenje z zaviralci tirozin-kinaze (TKI, tyrosine kinase inhibitor) odporni ali ga niso prenašali, so ocenili v odprtem, mednarodnem multicentričnem preskušanju z eno skupino.
English: Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia.
Slovenian: Zdravilo Iclusig je povezano s hudo (3. ali 4. stopnje po Poenotenih kriterijih za neželene učinke Nacionalnega inštituta za raka) trombocitopenijo, nevtropenijo in anemijo.
English: Ponatinib is mainly eliminated via faeces.
Slovenian: Ponatinib se v glavnem izloča z blatom.
English: • palpitation
Slovenian: • palpitacije
English: Of 43 CP-CML patients, 31 CP-CML patients achieved a MCyR with a median duration of follow-up of 25.3 months (range: 1.7 to 38.4 months).
Slovenian: Med 43 bolniki s CP-KML je 31 bolnikov s CP-KML doseglo MCyR z mediano trajanja spremljanja 25,3 mesece (razpon: 1,7 do 38,4 mesecev).
English: In patients with moderate or severe hepatic impairment, ponatinib Cmax and AUC0-∞ were lower and ponatinib plasma elimination half-life was longer in patients with mild, moderate, and severe hepatic impairment but not clinically significantly different than in healthy volunteers with normal hepatic function.
Slovenian: Pri bolnikih z zmerno do hudo okvaro jeter sta bila Cmax in AUC0-∞ ponatiniba manjša, razpolovni čas izločanja ponatiniba iz plazme pa je bil daljši pri bolnikih z blago, zmerno in hudo okvaro jeter, vendar ni bil klinično pomembno drugačen kot pri zdravih prostovoljcih z normalnim delovanjem jeter.
English: Grade 4 pancreatitis
Slovenian: Pankreatitis 4. stopnje
English: Iclusig therapy should be prescribed by a doctor experienced in leukaemia treatment.
Slovenian: Zdravljenje z zdravilom Iclusig mora predpisati zdravnik z izkušnjami v zdravljenju levkemije.
English: During Iclusig treatment, blood pressure should be monitored and managed at each clinic visit and hypertension should be treated to normal.
Slovenian: Med zdravljenjem z zdravilom Iclusig je treba ob vsakem obisku zdravnika spremljati krvni tlak in zdraviti hipertenzijo, da se vrne na normalno raven.
English: Within the range of clinically relevant doses evaluated in patients (15 mg to 60 mg), ponatinib exhibited dose proportional increases in both Cmax and AUC.
Slovenian: V klinično pomembnem razponu odmerkov, ki so ga ocenili pri bolnikih (15 mg do 60 mg), je ponatinib pokazal zvišanja Cmax in AUC, sorazmerna z odmerkom.
English: Table 4 Incidence of clinically relevant grade 3/4* laboratory abnormalities in ≥2% of patients in any disease group Laboratory Test
Slovenian: stopnje* pri ≥ 2 % bolnikov v vsaki skupini bolezni Laboratorijski test
English: • narrowing of the arteries in the brain
Slovenian: • zoženje arterij v možganih