FrancophonIA/ELRC3.0 huggingface dataset:
English: In CP-CML patients who achieved MCyR, the median time to MCyR was 84 days (range: 49 to 334 days) and in patients who achieved MMR, the median time to MMR was 167 days (range: 55 to 421 days).
Slovenian: Pri bolnikih s CP-KML, ki so dosegli MCyR, je bila mediana časa do MCyR 84 dni (razpon: 49 do 334 dni), pri bolnikih, ki so dosegli MMR, pa je bila mediana časa do MMR 167 dni (razpon: 55 do 421 dni).
English: At doses of 30 mg or greater plasma steady state trough concentrations of ponatinib typically exceed 21 ng/mL (40 nM).
Slovenian: Pri odmerkih 30 mg ali več je koncentracija ponatiniba v stanju dinamičnega ravnovesja običajno presegla 21 ng/ml (40 nM).
English: AP-CML (N=85)
Slovenian: AP-KML (N = 85)
English: • increased blood sugar or uric acid levels in the blood, high blood fat values of triglycerides
Slovenian: • zvišane ravni sladkorja ali sečne kisline v krvi, visoke vrednosti maščob (trigliceridov) v krvi
English: If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2).
Slovenian: Če zvišanje ravni lipaz spremljajo abdominalni simptomi, je treba z uporabo zdravila Iclusig prenehati in preveriti, ali ima bolnik pankreatitis (glejte poglavje 4.2).
English: In vitro studies indicate that clinical medicinal product interactions are unlikely to occur as a result of ponatinib-mediated inhibition of the metabolism of substrates for CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A or CYP2D6.
Slovenian: Študije in vitro kažejo, da ni verjetno, da bi se pojavilo klinično medsebojno delovanje med zdravili kot posledica zaviranja presnove substratov za CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A ali CYP2D6, pri kateri posreduje ponatinib.
English: ARIAD Pharma Ltd.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM ARIAD Pharma Ltd.
English: • lung infection, blood infection, inflammation of hair follicles
Slovenian: • okužba pljuč, okužba krvi, vnetje lasnih foliklov
English: • a liver or pancreas disorder or reduced kidney function.
Slovenian: • bolezen jeter ali trebušne slinavke ali zmanjšano delovanje ledvic.
English: CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses.
Slovenian: Bolniki s CP-KML, ki so se predhodno zdravili s TKI, so dosegali višje citogenetske, hematološke in molekularne odgovore.
English: 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.
Slovenian: Stopnje pojavnosti neželenih učinkov zaradi zdravljenja, zaradi katerih je bilo treba zdravljenje prekiniti, so bile 14 % za CP-KML, 7 % za AP-KML in 4 % za BP-KML/Ph+ ALL.
English: • night sweats, increased sweating
Slovenian: • nočno potenje, povečano potenje
English: High density polyethylene (HDPE) bottles with screw-top closures, containing either 60 or 180 film-coated tablets, together with one plastic canister containing molecular sieve desiccant.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z navojno zaporko, ki vsebujejo 60 ali 180 filmsko obloženih tablet, skupaj s plastično posodo s sušilnim sredstvom, ki vsebuje molekulsko sito.
English: No clinically significant changes in the mean QTc interval (i.e., > 20 ms) from baseline were detected in the study.
Slovenian: V študiji niso ugotovili klinično pomembnih sprememb povprečnega intervala QTc (tj. > 20 ms) glede na izhodišče.
English: • a complete blood count This will be repeated every 2 weeks for the first 3 months after starting the therapy.
Slovenian: • opravil pregled celotne krvne slike Prve 3 mesece po uvedbi zdravljenja se bo ta preiskava ponavljala vsaka 2 tedna.
English: Overall arterial and venous occlusive adverse reactions have occurred in 23% of Iclusig-treated patients from the phase 2 trial, with serious adverse reactions occurring in 18% of patients.
Slovenian: Splošni arterijski in venski okluzivni neželeni dogodki so se pojavili pri 23 % bolnikov, zdravljenih z zdravilom Iclusig v preskušanju 2. faze, pri čemer so se resin neželeni učinki pojavili pri 18 % bolnikov.
English: Table 3 Adverse reactions observed in CML and Ph+ ALL patients - frequency reported by incidence of treatment emergent events System organ class
Slovenian: Preglednica 3 Neželeni učinki, ki so jih opazili pri bolnikih s KML in Ph+ ALL - pogostnost incidenc glede na poročila o dogodkih Organski sistem
English: For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available.
Slovenian: Za odmerek 30 mg ali 15 mg enkrat na dan so na voljo 15 mg filmsko obložene tablete.
English: Ponatinib is metabolized to an inactive carboxylic acid by esterases and/or amidases, and metabolized by CYP3A4 to an N-desmethyl metabolite that is 4 times less active than ponatinib.
Slovenian: Ponatinib se z esterazami in/ali amidazami presnavlja v neaktivno karboksilno kislino, CYP3A4 pa ga presnovi v presnovek N-desmetil, ki je 4-krat manj aktiven kot ponatinib.
English: Concomitant use of ponatinib with anti-clotting agents should be approached with caution in patients who may be at risk of bleeding events (see “Myelosuppression” and “Haemorrhage”).
Slovenian: Pri sočasni uporabi ponatiniba z zdravili proti strjevanju je pri bolnikih, pri katerih obstaja tveganje za krvavitev, potrebna previdnost (glejte "Mielosupresija" in "Krvavitev").
English: Grade 3 pancreatitis
Slovenian: Pankreatitis 3. stopnje
English: In vitro, ponatinib is an inhibitor of P-gp and BCRP.
Slovenian: Ponatinib je in vitro zaviralec P-gp in BCRP.
English: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate Colloidal anhydrous silica Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karboksimetilškrob kolodni brezvodni silicijev dioksid magnezijev stearat
English: - amylase
Slovenian: - amilaze
English: • narrowing of the blood vessels, poor blood circulation
Slovenian: • zoženje krvnih žil, slab krvni obtok
English: (95% CI) Completeb (CHR)
Slovenian: (95 % IZ) Celovitb (CHR)
English: At therapeutic serum concentrations, ponatinib did not inhibit OATP1B1 or OATP1B3, OCT1 or OCT2, organic anion transporters OAT1 or OAT3, or bile salt export pump (BSEP) in vitro.
Slovenian: V terapevtskih koncentracijah ponatinib in vitro ni zaviral OATP1B1 ali OATP1B3, OCT1 ali OCT2, organska anionska prenašalca OAT1 ali OAT3 ali črpalke žolčnih soli (BSEP, bile salt export pump).
English: Myelosuppression was commonly reported in all patient populations.
Slovenian: Pri vseh skupinah bolnikov so pogosto poročali o mielosupresiji.
English: Ponatinib Cmax was comparable in patients with mild hepatic impairment and healthy volunteers with normal hepatic function.
Slovenian: Cmax ponatiniba je bil pri bolnikih z blago okvaro jeter in pri zdravih prostovoljcih z normalnim delovanjem jeter primerljiv.
English: Each film-coated tablet contains 120 mg of lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 120 mg laktoze monohidrata.
English: Ponatinib did not adversely affect important developmental parameters in the juvenile toxicity study.
Slovenian: V študiji juvenilne toksičnosti ponatinib ni neželeno vplival na pomembne razvojne parametre.
English: • lethargy, migraine
Slovenian: • otopelost, migrena
English: It is unknown whether Iclusig is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Iclusig izloča v materino mleko pri človeku.
English: Breast-feeding should be stopped during treatment with Iclusig.
Slovenian: Z dojenjem je treba med zdravljenjem z zdravilom Iclusig prenehati.
English: Iclusig has not been studied in patients with renal impairment.
Slovenian: Zdravila Iclusig niso preučevali pri bolnikih z okvarjenim delovanjem ledvic.
English: In the case of severe adverse reactions, treatment should be withheld.
Slovenian: V primeru hudih neželenih učinkov je treba z zdravljenjem začasno prenehati.
English: Bottles of Iclusig 15 mg contain either 60 or 180 film-coated tablets.
Slovenian: Plastenke zdravila Iclusig 15 mg vsebujejo 60 ali 180 filmsko obloženih tablet.
English: • Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): a type of leukaemia involving too many immature white blood cells in the blood and blood forming bone marrow.
Slovenian: • akutna limfoblastna levkemija s prisotnim kromosomom Philadelphia (Ph+ ALL): vrsta levkemije, ki vključuje preveč nezrelih belih krvnih celic v krvi in krvotvornem kostnem mozgu.
English: Patients should be advised not to swallow the desiccant canister found in the bottle.
Slovenian: Bolnikom je treba svetovati, naj posode s sušilnim sredstvom, ki je v plastenki, ne pogoltnejo.
English: • a heart rhythm disorder, abnormal pulse
Slovenian: • motnja srčnega ritma, nenormalen srčni utrip
English: Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
Slovenian: Zdravilo Iclusig lahko zviša ravni ALT, AST, bilirubina in alkalne fosfataze.
English: It is not known if Iclusig passes into breast milk.
Slovenian: Ni znano, ali zdravilo Iclusig prehaja v materino mleko.
English: Bottles of Iclusig 45 mg contain either 30 or 90 film-coated tablets.
Slovenian: Plastenke zdravila Iclusig 45 mg vsebujejo 30 ali 90 filmsko obloženih tablet.
English: Achieved MMR at 45 mg (N=63)
Slovenian: Dosežen MMR pri 45 mg (N=63)
English: Achieved MCyR at 30 mg (N=45)
Slovenian: Dosežen MCyR pri 30 mg (N=45)
English: Men receiving treatment with Iclusig are advised not to father a child during treatment.
Slovenian: Moškim, ki se zdravijo z zdravilom Iclusig, svetujemo, naj med zdravljenjem ne zaplodijo otroka.
English: The following medicines can affect or be affected by Iclusig:
Slovenian: Naslednja zdravila lahko vplivajo na način delovanja zdravila Iclusig ali pa lahko zdravilo Iclusig vpliva na delovanje teh zdravil:
English: Table 6 Efficacy of Iclusig in resistant or intolerant chronic phase CML patients Overall (N=267)
Slovenian: Preglednica 6 Učinkovitost zdravila Iclusig pri bolnikih s kronično fazo KML, ki so na zdravljenje odporni ali ga ne prenašajo Skupaj (N = 267)
English: Treatment was interrupted, the events resolved, and Iclusig was restarted at 45 mg, once daily.
Slovenian: Zdravljenje je bilo prekinjeno, zdravilo Iclusig pa je bilo ponovno uvedeno z odmerkom 45 mg enkrat na dan, ko je dogodek izzvenel.
English: Table 9 Vascular Occlusive First Adverse Events in CP-CML Patients who Achieved MCyR at 45 mg or 30 mg (data extraction 7 April 2014) Most Recent Dose at Onset of First Vascular Occlusive Event
Slovenian: Preglednica 9 Vaskularni okluzivni prvi neželeni učinki pri bolnikih s CP-KML, ki so dosegli MCyR pri 45 mg ali 30 mg (ekstrakcija podatkov 7. aprila 2014) Zadnji odmerek pri začetku prvega vaskularnega okluzivnega dogodka
English: • 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)
Slovenian: • krvni strdek v globokih venah, nenadna zapora ven, krvni strdek v krvni žili pljuč (simptomi vključujejo vročinske valove, zardevanje, pordelost obraza, težave z dihanjem)
English: Caution should be exercised with concurrent use of Iclusig and moderate and strong CYP3A inhibitors and moderate and strong CYP3A inducers (see section 4.5).
Slovenian: Pri sočasni uporabi zdravila Iclusig in zmernimi in močnimi zaviralci CYP3A ter zmernimi in močnimi induktorji CYP3A je potrebna previdnost(glejte poglavje 4.5).
English: Blast Phase CML
Slovenian: KML v blastni fazi
English: Iclusig with food and drink Avoid grapefruit products such as grapefruit juice.
Slovenian: Ne uporabljajte izdelkov iz grenivke, kot je na primer sok grenivke.
English: CP-CML patients who experienced a loss of response or development of a kinase domain mutation in the absence of a complete cytogenetic response or progression to AP-CML or BP-CML at any time on dasatinib or nilotinib were also considered resistant.
Slovenian: Bolniki s CP-KML z izgubo odgovora, z razvojem mutacije domene kinaze v odsotnosti celovitega citogenetskega odgovora ali z napredovanjem do AP-KML ali BP-KML kadar koli v času prejemanja dasatiniba ali nilotiniba so bili prav tako obravnavani kot odporni.
English: Intolerance was defined as the discontinuation of dasatinib or nilotinib due to toxicities despite optimal management in the absence of a complete cytogenetic response for CP CML patients or major haematological response for AP CML, BP CML, or Ph+ ALL patients.
Slovenian: Neprenašanje so opredelili kot prekinitev uporabe dasatiniba ali nilotiniba zaradi toksičnosti kljub optimalni obravnavi, v odsotnosti celovitega citogenetskega odgovora pri bolnikih CP KML ali bistvenega hematološkega odgovora pri bolnikih z AP KML, BP KML ali Ph+ ALL.
English: 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.
Slovenian: Med bolniki s CP-KML, predhodno zdravljenimi z enim, dvema ali tremi TKI, jih je med uporabo zdravila Iclusig MCyR doseglo 81 % (13/16) oz. 61 % (65/105) oz. 46 % (66/143).
English: 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.
Slovenian: S ponatinibom povezane mikroskopske izsledke na jajčnikih (vključno z atrezijo foliklov) in modih (minimalna degeneracija zarodnih celic) pri živalih, ki so dobivale 5 mg/kg ponatiniba, so opazili v študiji toksičnosti pri ponavljajočih se odmerkih pri opicah cynomolgus.
English: For patients whose adverse reactions are resolved or attenuated in severity, Iclusig may be restarted and escalation of the dose back to the daily dose used prior to the adverse reaction may be considered, if clinically appropriate.
Slovenian: Pri bolnikih, pri katerih neželeni učinki izzvenijo ali se njihova resnost zmanjša, se lahko zdravljenje z zdravilom Iclusig nadaljuje in če je klinično ustrezno, se lahko odmerek stopnjuje nazaj do dnevnega odmerka, doseženega pred neželenim učinkom.
English: The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML and Ph+ ALL.
Slovenian: Incidenca resnih krvavitev je bila večja pri bolnikih z AP-KML, BP-KML in Ph+ ALL.
English: Caution is recommended in when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min or end-stage renal disease (see section 4.2).
Slovenian: Previdnost se priporoča pri dajanju zdravila Iclusig bolnikom z ocenjenim očistkom kreatinina < 50 ml/min ali ledvično boleznijo v zadnjem stadiju (glejte poglavje 4.2).
English: A break in treatment or a decrease in dose may be required when lipase is increased.
Slovenian: Pri zvišanju lipaze bo morda treba zdravljenje prekiniti ali zmanjšati odmerek.
English: 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.
Slovenian: Za vse bolnike v preskušanju 2. faze razmerje med intenzivnostjo odmerjanja in varnostjo kaže, da v razponu odmerkov od 15 do 45 mg enkrat na dan obstaja značilno povečanje neželenih učinkov stopnje ≥ 3 (srčno popuščanje, arterijska tromboza, hipertenzija, trombocitopenija, pankreatitis, nevtropenija, izpuščaj, povečanje vrednosti ALT, povečanje vrednosti AST, povečanje vrednosti lipaze, mielosupresija).
English: • you develop heart or blood vessel problems.
Slovenian: • se pojavijo težave s srcem ali krvnimi žilami
English: An in vitro study in human hepatocytes indicated that clinical medicinal product interactions are also unlikely to occur as a result of ponatinib-mediated induction of the metabolism of substrates for CYP1A2, CYP2B6, or CYP3A.
Slovenian: Študija in vitro s človeškimi hepatociti kaže, da ni verjetno, da bi se pojavilo klinično medsebojno delovanje med zdravili kot posledica indukcije presnove substratov za CYP1A2, CYP2B6 ali CYP3A, pri kateri posreduje ponatinib.
English: Table 10 Maintenance of response in CP-CML patients who achieved MCyR or MMR at 45 mg dose (data extraction 7 April 2014) Achieved MCyR at 45 mg (N=87)
Slovenian: Preglednica 10 Vzdrževanje odgovora pri bolnikih s CP-KML, ki so dosegli MCyR ali MMR pri odmerku 45 mg (ekstrakcija podatkov 7. aprila 2014) Dosežen MCyR pri 45 mg (N=87)
English: • pain in muscles, skeletal system, neck or chest
Slovenian: • bolečine v mišicah, kosteh, vratu ali prsnem košu
English: The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 21 days (range: 12 to 176 days), 29 days (range: 12 to 113 days), and 20 days (range: 11 to 168 days), respectively.
Slovenian: Mediana časa do MaHR pri bolnikih z AP-KML, BP-KML in Ph+ ALL je bila 21 dni (razpon: 12 do 176 dni), 29 dni (razpon: 12 do 113 dni) oz. 20 dni (razpon: 11 do 168 dni).
English: Haematologic support such as platelet transfusion and haematopoietic growth factors can be used during treatment if clinically indicated.
Slovenian: Med zdravljenjem se lahko bolniku nudi hematološka podpora v obliki transfuzije trombocitov in hematopoetskega rastnega faktorja, če je to klinično indicirano.
English: • blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs)
Slovenian: • težave s krvnim obtokom (simptomi vključujejo bolečino v rokah ali nogah, hladnost oddaljenih delov udov)
English: • clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections.
Slovenian: • klaritromicin, telitromicin, troleandomicin: zdravila za zdravljenje bakterijskih okužb
English: • increased tendency to bleed or bruise
Slovenian: • povečano nagnjenost h krvavitvam ali nastanku podplutb
English: • methotrexate: a medicine to treat severe joint inflammation (rheumatoid arthritis), cancer and the skin disease psoriasis.
Slovenian: • metotreksat: zdravilo za zdravljenje hudega vnetja sklepov (revmatoidni artritis), raka in kožne bolezni luskavice
English: Serious vascular occlusion has occurred in patients treated with Iclusig, including cardiovascular, cerebrovascular and peripheral vascular events, and venous thrombotic events.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Iclusig, se je pojavila resna žilna okluzija, vključno s kardiovaskularnimi, cerebrovaskularnimi in perifernimi žilnimi dogodki in venskimi trombotičnimi dogodki.
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 40 mg laktoze monohidrata.
English: • heart problems, problems of the blood vessels in the heart muscle, left sided chest pain, dysfunction of the left heart chamber
Slovenian: • težave s srcem, težave s krvnimi žilami v srčni mišici, bolečine na levi strani prsnega koša,
English: Achieved MCyR at 45 mg (N=87)
Slovenian: Dosežen MCyR pri 45 mg (N=87)
English: The secondary efficacy endpoints in AP-CML and BP-CML/Ph+ ALL were MCyR and MMR.
Slovenian: Sekundarna opazovana dogodka učinkovitosti pri bolnikih z AP-KML in BP-KML/Ph+ ALL sta bila MCyR in MMR.
English: Resistance in CP-CML was defined as failure to achieve either a complete haematological response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months) while on dasatinib or nilotinib.
Slovenian: Odpornost pri CP-KML je bila opredeljena kot nedoseganje celovitega hematološkega odgovora (po 3 mesecih), manjši citogenetski odgovor (po 6 mesecih) ali bistven citogenetski odgovor (po 12 mesecih) med uporabo dasatiniba ali nilotiniba.
English: Caution is recommended in patients with a history of pancreatitis or alcohol abuse.
Slovenian: Pri bolnikih s pankreatitisom ali zlorabo alkohola v anamnezi se priporoča previdnost.
English: • tissue swelling in eyelid or around the eyes, caused by excess fluid
Slovenian: • oteklost tkiva vek ali okoli oči zaradi odvečne tekočine
English: Resistance in AP-CML and BP-CML/Ph+ ALL was defined as failure to achieve either a major haematological response (AP-CML by 3 months, BP-CML/Ph+ ALL by 1 month), loss of major haematological response (at any time), or development of kinase domain mutation in the absence of a major haematological response while on dasatinib or nilotinib.
Slovenian: Odpornost pri AP-KML in BP-KML/Ph+ ALL je bila opredeljena kot nezmožnost doseganja bodisi bistvenega hematološkega odgovora (AP-KML po 3 mesecih, BP-KML/Ph+ ALL po 1 mesecu), izguba bistvenega hematološkega odgovora (kadar koli) ali razvoj mutacije domene kinaze v odsotnosti bistvenega hematološkega odgovora med prejemanjem dasatiniba ali nilotiniba.
English: Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporters OCT-1.
Slovenian: Ponatinib ni substrat za humana organska anionska prenašalska polipeptide OATP1B1 in OATP1B3 ter za organski kationski prenašalec OCT-1.
English: Resistant or Intolerant R/I Cohort (N=10)
Slovenian: Odporni ali ne prenašajo O/N kohorta (N = 10)
English: Dose modifications or interruption of dosing should be considered for the management of haematological and non-haematological toxicities.
Slovenian: Pri obravnavi hematoloških in nehematoloških toksičnosti je treba razmisliti o prilagoditvi ali prekinitvi odmerjanja.
English: • heartburn caused by reflux of stomach juices, inflammation in the mouth, abdominal swelling or discomfort or indigestion, dry mouth
Slovenian: • zgaga, ki jo povzroča zatekanje želodčnih sokov v požiralnik, vnetje v ustih, otekanje trebuha ali napetost v trebuhu ali prebavne motnje, suha usta
English: Based on the Kaplan-Meier estimates, 87% (95% CI: [78%-92%]) of CP-CML patients (median duration of treatment: 866 days) who achieved a MCyR and 66% (95% CI: [55%- 75%]) of CP-CML patients who achieved a MMR are projected to maintain that response at 24 months.
Slovenian: Na podlagi ocene Kaplan-Meier se projicira, da bo 87 % (95-% IZ: [78 %-92 %]) bolnikov s CP-KML (mediana trajanja zdravljenja: 866 dni), ki so dosegli MCyR in 66 % (95-% IZ: [55 %-75%]) bolnikov s CP-KML, ki so dosegli MMR, ohranilo odgovor še v 24. mesecu.
English: • a 15 mg film-coated tablet to allow for dose adjustments.
Slovenian: • 15 mg filmsko obložene tablete za prilagajanje odmerka.
English: • mini stroke, cerebral infarction
Slovenian: • mala možganska kap, možganski infarkt
English: 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.
Slovenian: Ponatinib v odmerkih 3, 10 in 30 mg/kg je v študiji farmakološke varnosti pri podganah povzročil povečanje količine urina in izločanja elektrolitov ter manjše praznjenje želodca.
English: Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 3.
Slovenian: Neželeni učinki, o katerih so poročali za vse bolnike s KML in Ph+ ALL, so predstavljeni v preglednici 3.
English: Co-administration of a single 45 mg dose of Iclusig in the presence of rifampin (600 mg daily), a strong CYP3A inducer, to 19 healthy volunteers, decreased the AUC0-∞ and Cmax of ponatinib by 62% and 42%, respectively, when compared to administration of ponatinib alone.
Slovenian: Sočasna uporaba enega 45-mg odmerka zdravila Iclusig v prisotnosti rifampina (600 mg na dan), močnega induktorja CYP3A, 19 zdravim prostovoljcem, je zmanjšala vrednost AUC0-∞ ponatiniba za 62 % in Cmax za 42 %, v primerjavi z dajanjem ponatiniba samega.
English: • stomach bleeding (symptoms include: stomach pain, vomiting blood)
Slovenian: • krvavitev v želodcu (simptomi vključujejo: bolečino v želodcu, bruhanje krvi)
English: How to take Iclusig
Slovenian: Kako jemati zdravilo Iclusig
English: Iclusig is available in plastic bottles, each containing one canister of molecular sieve desiccant.
Slovenian: Zdravilo Iclusig je na voljo v plastenkah, od katerih vsaka vsebuje eno posodo s sušilnim sredstvom z molekulskim sitom.