natgillin/translations-raw huggingface dataset:
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).
Za bolesnike u kroničnoj fazi KML koji su postigli MCyR medijan vremena do postizanja MCyR iznosio je 84 dana (raspon: 49 do 334 dana), a u bolesnika koji su postigli MMR medijan vremena do postizanja MMR iznosio je 167 dana (raspon: 55 do 421 dana).
Breast-feeding should be stopped during treatment with Iclusig.
Dojenje treba prekinuti za vrijeme liječenja lijekom Iclusig.
An effective method of contraception should be used during treatment.
Za vrijeme liječenja potrebno je koristiti učinkovite metode kontracepcije.
• heart problems, problems of the blood vessels in the heart muscle, left sided chest pain, dysfunction of the left heart chamber
• problemi sa srcem, problemi s krvnim žilama u srčanom mišiću, bol na lijevoj strani prsišta,
Achieved MCyR at 30 mg (N=45)
Postignut MCyR pri 30 mg (N=45)
Treatment was interrupted, the events resolved, and Iclusig was restarted at 45 mg, once daily.
Nakon prekida liječenja došlo je do povlačenja opisanih štetnih događaja te je nastavljeno liječenje lijekom Iclusig 45 mg, jednom dnevno.
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.
U bolesnika s umjerenim ili teškim oštećenjem jetre, Cmax i AUC0-∞ ponatiniba bili su sniženi a poluvijek eliminacije ponatiniba iz plazme u bolesnika s blagim, umjerenim i teškim oštećenjem jetre bio je dulji ali ne klinički značajno različit od onog u zdravih dobrovoljaca s normalnom funkcijom jetre.
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.
In vitro ispitivanja na humanim hepatocitima ukazuju da kliničke interakcije lijekova također nisu vjerojatne kao rezultat indukcije metabolizma supstrata za CYP1A2, CYP2B6 ili CYP3A posredovane ponatinibom.
Caution is recommended when administering Iclusig to patients with severe hepatic impairment (see section 5.2).
Preporučuje se oprez prilikom primjene lijeka Iclusig u bolesnika s teškim oštećenjem jetre (vidjeti dio 5.2).
• Consider discontinuing Iclusig
• Razmotrite prekid liječenja Iclusigom
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.
In vitro ispitivanja ukazuju da kliničke interakcije lijekova nisu vjerojatne kao rezultat inhibicije metabolizma supstrata enzima CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A ili CYP2D6 koji je posredovan ponatinibom.
• a 45 mg film-coated tablet for the recommended dose.
• filmom obložene tablete od 45 mg za preporučenu dozu.
This medicinal product contains lactose monohydrate.
Ovaj lijek sadrži laktozu hidrat.
• circulatory problems in the spleen
• problemi s cirkulacijom u slezeni
The recommended starting dose is one 45 mg film-coated tablet once daily.
Preporučena početna doza je jedna filmom obložena tableta od 45 mg jednom dnevno.
With once daily dosing, plasma exposures of ponatinib are increased by approximately 1.5-fold between first dose andsteady state conditions.
Pri doziranju jednom dnevno izloženost ponatinibu u plazmi povećava se za približno 1,5 puta između prve doze i stanja dinamičke ravnoteže.
• a complete blood count This will be repeated every 2 weeks for the first 3 months after starting the therapy.
To će se ponavljati svaka 2 tjedna tijekom prva 3 mjeseca nakon početka liječenja.
Dose interruption or reduction may be required.
Možda će biti potrebno prekinuti liječenje ili smanjiti dozu.
Iclusig is associated with severe (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4) thrombocytopenia, neutropenia, and anaemia.
Liječenje lijekom Iclusig je povezano je s teškom (Opći kriteriji toksičnosti 3. ili 4. stupnja Nacionalnog instituta za karcinome - National Cancer Institute) trombocitopenijom, neutropenijom i anemijom.
How to store Iclusig
Kako čuvati Iclusig
Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively.
Ponatinib inhibira aktivnost tirozin kinaze ABL I T315I mutanta ABL s vrijednostima IC50 od 0,4 odnosno 2,0 nM.
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.
Medijan trajanja liječenja bio je 866 dana za bolesnike u kroničnoj fazi (CP-KML), 590 dana za bolesnike u ubrzanoj fazi (AP-KML) i 86 dana za bolesnike u blastičnoj fazi (BP-KML) /Ph+ ALL.
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.
Prije početka liječenja ponatinibom, mora se ocijeniti kardiovaskularno stanje bolesnika, uključujući povijest bolesti i fizikalni pregled, a kardiovaskularni čimbenici rizika moraju se aktivno zbrinuti.
The frequency of these events is greater in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML).
Učestalost tih događaja veća je u bolesnika s ubrzanom fazom KML (AP-KML) ili blastičnom fazom KML (BP-KML)/Ph+ ALL nego u kroničnoj fazi KML (CP-KML).
• blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs)
• problemi s cirkulacijom krvi (simptomi uključuju: bolove u nogama ili rukama, hladnoću na krajevima udova)
Poly(vinyl alcohol) Titanium dioxide (E171)
Ovojnica tablete talk makrogol 4000 poli(vinilni alkohol) titanijev dioksid (E171)
It is unknown whether Iclusig is excreted in human milk.
Nije poznato izlučuje li se Iclusig u majčino mlijeko u ljudi.
Grade 4 pancreatitis
Pankreatitis 4. stupnja
Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.
Mijelosupresija je opisana i kod bolesnika koji su na početku liječenja imali uredne laboratorijske nalaze kao i kod bolesnika s već postojećim patološkim laboratorijskim nalazima.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
• akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) koji su rezistentni na dasatinib; koji ne podnose dasatinib i za koje naknadno liječenje imatinibom nije klinički opravdano; ili koji imaju T315I mutaciju.
• a 15 mg film-coated tablet to allow for dose adjustments.
• filmom obložene tablete od 15 mg za prilagođavanje doze.
• sulfasalazine: a medicine to treat severe bowel and rheumatic joint inflammation.
• sulfasalazin: lijek za liječenje teške upale crijeva i reumatske upale zglobova.
In 67% of CP-CML patients in the R/I cohort, no mutations were detected at study entry.
U 67% bolesnika u kroničnoj fazi KML u kohorti R/I nisu uočene mutacije prilikom uključivanja.
• colchicine: a medicine to treat gout attacks.
• kolhicin: lijek za liječenje napadaja gihta.
Uncommon tumour lysis syndrome
Manje često sindrom lize tumora
• stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations)
• moždani udar (simptomi uključuju: otežan govor i pokrete, pospanost, migrenu, abnormalne osjete)
• heartburn caused by reflux of stomach juices, inflammation in the mouth, abdominal swelling or discomfort or indigestion, dry mouth
• žgaravica uzrokovana povratom sokova iz želuca, upala u ustima, nadutost trbuha ili nelagoda ili probavne tegobe, suha usta
The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BP-CML/Ph+ ALL than in patients with CP-CML (see Table 4).
Učestalost stupnja 3 ili 4 trombocitopenije, neutropenije i anemije bila je viša u bolesnika s AP-KML i BP-KML/Ph+ ALL nego u bolesnika s CP-KML (vidjeti tablicu 4).
For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available.
Za dozu od 30 mg ili 15 mg jednom dnevno dostupne su filmom obložene tablete od 15 mg.
• phenobarbital, phenytoin: medicines to treat epilepsy.
• fenobarbital, fenitoin: lijekovi za liječenje epilepsije.
Resistant or Intolerant R/I Cohort (N=10)
Rezistentan ili intolerantan R/I kohorta (N=10)
Adverse reactions reported in all CML and Ph+ ALL patients are presented in Table 3.
Nuspojave prijavljene kod svih KML i Ph+ ALL bolesnika prikazane su u Tablici
• skin rash, itching, peeling of the skin, redness, bruising, skin pain, hair loss
• kožni osip, svrbež, ljuštenje kože, crvenilo, nastanak modrica, bol po koži, gubitak kose
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
Tablica 9 Prvi štetni događaji vaskularne okluzije u bolesnika u kroničnoj fazi KML koji su postigli MCyR pri dozi od 45 mg ili 30 mg (podatci od 7. travnja 2014.) Zadnja doza pri pojavi prvog štetnog događaja vaskularne okluzije
Achieved MCyR at 45 mg (N=87)
Postignut MCyR pri 45 mg (N=87)
• liver damage, jaundice (symptoms include: yellowing of the skin and eyes)
• oštećenje jetre, žutica (simptomi uključuju: žutilo kože i bjeloočnica)
6.6 Special precautions for disposal and other handling Disposal:
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Zbrinjavanje:
No clinically significant changes in the mean QTc interval (i.e., > 20 ms) from baseline were detected in the study.
Nisu uočene kliničke promjene u prosječnom intervalu QTc (primjerice > 20 ms) od početne vrijednosti.
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).
Od 43 bolesnika u kroničnoj fazi KML, 31 je postigao MCyR s medijanom praćenja od 25,3 mjeseca (raspon: 1,7 da 38,4 mjeseca).
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.
Pri terapijskim koncentracijama u serumu ponatinib nije inhibirao OATP1B1 ili OATP1B3, OCT1 ili OCT2 transportere organskih aniona OATP1B1 ili OATP1B3, transportere organskih kationa OCT1 ili OCT2, organskih aniona OAT1 ili OAT3 ili crpku za izbacivanje žučne soli (BSEP) u in vitro uvjetima.
The blood/plasma ratio of ponatinib is 0.96.
Omjer ponatiniba u krvi i plazmi iznosio je 0,96.
• clarithromycin, telithromycin, troleandomycin: medicines to treat bacterial infections.
• klaritromicin, telitromicin, troleandomicin: lijekovi za liječenje bakterijskih infekcija.
- alanine aminotransferase
alanin aminotransferaze aspartat aminotransferaze
Each film-coated tablet contains 120 mg of lactose monohydrate.
Svaka filmom obložena tableta sadrži 120 mg laktoze hidrata.
Vascular occlusive adverse events were more frequent with increasing age and in patients with prior history of ischaemia, hypertension, diabetes, or hyperlipidaemia.
Štetni događaji vaskularne okluzije bivali su češći s porastom godina i u bolesnika s prethodnom anamnezom ishemije, hipertenzije, dijabetesa, ili hiperlipidemije.
Hyper-/hypoplastic changes of the chondrocytes in the physis were noted in repeat-dose toxicity studies in rats.
Hiper/hipoplastične promjene hondrocita u hrskavičnim pločama rasta kosti uočene su u studijama ponovljene toksičnosti u štakora.
In cellular assays, ponatinib was able to overcome imatinib, dasatinib, and nilotinib resistance mediated by BCR-ABL kinase domain mutations.
U kulturama stanica ponatinib je nadvladao rezistenciju na imatinib, dasatinib i nilotinib posredovanu mutacijama u domeni BCR-ABL kinaze.
Common chills, influenza like illness, non-cardiac chest pain, mass, face oedema
Često zimica, bolest nalik influenci, nekardijalna bol u prsištu, masa, edem lica
Serious vascular occlusion has occurred in patients treated with Iclusig, including cardiovascular, cerebrovascular and peripheral vascular events, and venous thrombotic events.
U bolesnika liječenih Iclusigom javila se ozbiljna vaskularna okluzija, uključujući kardiovaskularne, cerebrovaskularne i periferne vaskularne događaje, te venske trombotske događaje.
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.
Rezistencija bolesnika u kroničnoj fazi KML definirana je izostankom postizanja potpunog hematološkog odgovora (do 3 mjeseca), manjeg citogenetičkog odgovora (do 6 mjeseci) ili većeg citogenetičkog odgovora (do 12 mjeseci) za vrijeme liječenja dasatinibom ili nilotinibom.
Dry flaky skin was observed in toxicity studies in rats.
Suha, ljuskava koža uočena je u studijama toksičnosti u štakora.
• tissue swelling in eyelid or around the eyes, caused by excess fluid
• oticanje tkiva očnih kapaka ili područja oko očiju, uzrokovano prekomjernim nakupljanjem tekućine
If lipase elevations are accompanied by abdominal symptoms, Iclusig should be withheld and patients evaluated for evidence of pancreatitis (see section 4.2).
Ako je povišenje lipaza praćeno s abdominalnim simptomima, liječenje lijekom Iclusig se mora obustaviti a bolesnika dodatno dijagnostički obraditi zbog suspektnog pankreatitisa (vidjeti dio 4.2).
• increased blood levels of several liver enzymes called:
• povišene razine nekoliko jetrenih enzima u krvi:
Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporters OCT-1.
Ponatinib nije supstrat za polipeptide koji transportiraju humane organske anione OATP1B1, OATP1B3 i OCT-1 i transporter organskih kationa OCT-1.
Caution is recommended when administering Iclusig to patients with estimated creatinine clearance of < 50 mL/min, or end-stage renal disease.
Preporučuje se oprez prilikom primjene lijeka Iclusig bolesnicima s klirensom kreatinina < 50 ml/min ili s terminalnom fazom bubrežnog zatajenja.
Serious venous occlusive reactions (treatment-emergent frequencies) occurred in 4.5% of patients (see section 4.8).
Ozbiljne nuspojave venske okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 4,5% bolesnika (vidjeti dio 4.8).
Depletion of lymphoid organs was observed in repeat-dose toxicity studies in rats and cynomolgus monkeys.
Razaranje limfoidnih organa uočeno je u studijama ponovljene toksičnosti u štakora i makaki majmuna.
Adverse reactions such as lethargy, dizziness, and vision blurred have been associated with Iclusig.
Nuspojave poput letargije, omaglice i zamagljenog vida povezane su s lijekom Iclusig.
OUTER CARTON AND BOTTLE LABEL
KUTIJA I NALJEPNICA NA BOCI
• 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.
• akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ALL): tipa leukemije s previše nezrelih bijelih krvnih stanica u krvi i koštanoj srži, tkivu u kojem nastaju krvne stanice.
• fluid in the thorax (may cause breathing difficulty), nosebleed, difficulty producing voice sounds,
• tekućina u prsištu (može uzrokovati otežano disanje), krvarenje iz nosa, poteškoće u nastanku glasa, plućna hipertenzija
The secondary efficacy endpoints in CPCML were complete haematological response (CHR) and major molecular response (MMR).
Sekundarni ishodi za bolesnike u kroničnoj fazi KML bili su kompletni hematološki odgovor i veliki molekularni odgovor (MMR, engl. major molecular response).
• pain in muscles, skeletal system, neck or chest
• bol u mišićima, kostima, vratu ili prsištu
Occurrence at 45 mg:
Pojava uz 45 mg:
Periodic safety update reports
Periodička izvješća o neškodljivosti
A benefit-risk consideration should guide a decision to restart Iclusig therapy (see sections 4.4 and 4.8) after the event is resolved.
Odluka za ponovno uvođenje terapije Iclusigom mora biti vođena razmatranjem omjera koristi i rizika (vidjeti dio 4.4 i 4.8) nakon povlačenja štetnog događaja.
Co-administration of a single 15 mg oral dose of Iclusig in the presence of ketoconazole (400 mg daily), a strong CYP3A inhibitor, resulted in modest increases in ponatinib systemic exposure, with ponatinib AUC0-∞ and Cmax values that were 78% and 47% higher, respectively, than those seen when ponatinib was administered alone.
Istovremena peroralna primjena 15 mg lijeka Iclusig s ketokonazolom (400 mg dnevno), snažnim CYP3A inhibitorom uzrokovala je skromni porast u sistemskoj izloženosti ponatinibu s vrijednostima AUC0-∞ i Cmax ponatiniba koje su bile za 78% odnosno 47% više od onih uočenih kad se ponatinib primjenjivao sam.
Method of use
Način upotrebe
Monitoring for evidence of thromboembolism and vascular occlusion should be performed and Iclusig should be interrupted immediately in case of vascular occlusion.
Mora se provoditi praćenje na prisutnost tromboembolije i vaskularne okluzije, a u slučaju vaskularne okluzije liječenje Iclusigom se mora odmah prekinuti.
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.
Bolesnici u kroničnoj fazi KML koji nisu odgovorili na liječenje ili su razvili mutacije u domeni BCR-ABL kinaze u odsutnosti potpunog citogenetičkog odgovora ili progresije bolesti u ubrzanu ili blastičnu fazu u bilo koje vrijeme liječenja dasatinibom ili nilotinibom također se smatraju rezistentnim.
Iclusig contains lactose
Iclusig sadrži laktozu
INFORMATION IN BRAILLE Outer Carton:
16. PODACI NA BRAILLEOVOM PISMU Kutija:
Do not swallow the desiccant canister contained in the bottle.
Nemojte progutati spremnik sa sredstvom za sušenje koji se nalazi u boci.
• ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections.
• ketokonazol, itrakonazol, vorikonazol: lijekovi za liječenje gljivičnih infekcija.
Table 7 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Tablica 7 Djelotvornost lijeka Iclusig u bolesnika u uznapredovaloj fazi KML koji su rezistentni ili ne podnose lijek Ubrzana faza KML
Cytogenetic Response Major (MCyR) a
Citogenetički odgovor Značajni(MCyR) a
This is a long-term treatment.
Liječenje lijekom Iclusig je dugotrajno.
Common musculoskeletal pain, neck pain, musculoskeletal chest pain
Često muskuloskeletalna bol, bol u vratu, muskuloskeletalna bol u prsištu
• lung infection, blood infection, inflammation of hair follicles
• upala pluća, infekcija krvi, upala folikula kose
Following either a high-fat and low-fat meal, plasma ponatinib exposures (Cmax and AUC) were not different versus fasting conditions.
Izloženosti ponatinibu u plazmi (Cmax i AUC) nakon punomasnog i niskomasnog obroka nisu bile različite u odnosu na uvjete natašte.
Myelosuppression was generally reversible and usually managed by withholding Iclusig temporarily or reducing the dose (see section 4.2).
Mijelosupresija je obično reverzibilna i najčešće prolazi nakon privremenog prestanka primjene lijeka Inclusig ili nakon smanjenja doze (vidjeti dio
• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
• kroničnom mijeloičnom leukemijom (KML) u kroničnoj, ubrzanoj ili blastičnoj fazi bolesti koji su rezistentni na liječenje dasatinibom ili nilotinibom; koji ne podnose dasatinib ili nilotinib i za koje naknadno liječenje imatinibom nije klinički opravdano; ili koji imaju T315I mutaciju.
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)
Tablica 10 Održavanje odgovora u bolesnika u kroničnoj fazi KML koji su postigli MCyR ili MMR pri dozi od 45 mg (podatci od 7. travnja 2014.) Postignut MCyR pri 45 mg (N=87)
• fluid retention
• zadržavanje tekućine
• you develop heart or blood vessel problems.
• ako se jave problemi sa srcem ili krvnim žilama.
Achieved MMR at 45 mg (N=63)
Postignut MMR pri 45 mg (N=63)
Grade 3 pancreatitis
Pankreatitis 3. stupnja
A single dose of 30 mg ponatinib was administered to patients with mild, moderate, or severe hepatic impairment and to healthy volunteers with normal hepatic function.
Jednokratna doza ponatiniba od 30 mg primijenjena je u bolesnika s blagim, umjerenim, ili teškim oštećenjem jetre i u zdravih dobrovoljaca s normalnom funkcijom jetre.
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.
Rezistencija bolesnika u ubrzanoj fazi KML i blastičnoj fazi KML/Ph+ALL definirana je kao neuspjeh u postizanju bilo glavnog hematološkog odgovora (bolesnici u ubrzanoj fazi KML do 3 mjeseca, u blastičnoj fazi KML/Ph+ALL do 1 mjesec), ili kao gubitak glavnog hematološkog odgovora (bilo kada) ili razvoj mutacija u domeni BCR-ABL kinaze u odsutnosti glavnog hematološkog odgovora za vrijeme liječenja dasatinibom ili nilotinibom.
CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses.
Bolesnici u kroničnoj fazi KML koji su prethodno primali manje TKI terapija postigli su bolji citogenetičke, hematološke i molekularne odgovore.
Recurrence at 15 mg:
Ponovna pojava uz 15 mg:
Very common insomnia
Vrlo često nesanica
How to store Iclusig Keep this medicine out of the sight and reach of children.
Ovaj lijek čuvajte izvan pogleda i dohvata djece.
Peak concentrations of ponatinib are observed approximately 4 hours after oral administration.
Ponatinib doseže vršnu koncentraciju u plazmi približno četiri sata nakon peroralne primjene.
For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available.
Za standardnu dozu od 45 mg jednom dnevno, dostupne su 45 mg filmom obložene tablete.
• blurred vision, dry eye
• zamagljen vid, suhe oči
High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing molecular sieve desiccant.
Bočice od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 30 ili 90 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
Common pneumonia, sepsis, folliculitis
Često pneumonija, sepsa, folikulitis
• tissue swelling in face caused by excess fluid
• oticanje tkiva lica uzrokovano prekomjernim nakupljanjem tekućine
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.
Intolerancija se definira kao prekid liječenja dasatinibom ili nilotinibom zbog toksičnosti unatoč optimalnom liječenju u odsutnosti potpunog citogenetičkog odgovora za bolesnike u kroničnoj fazi ili glavnog hematološkog odgovora za bolesnike u ubrzanoj fazi, blastičnoj fazi ili s ALL.