FrancophonIA/ELRC3.0 huggingface dataset:
English: Depletion of lymphoid organs was observed in repeat-dose toxicity studies in rats and cynomolgus monkeys.
Croatian: Razaranje limfoidnih organa uočeno je u studijama ponovljene toksičnosti u štakora i makaki majmuna.
English: Adverse reactions such as lethargy, dizziness, and vision blurred have been associated with Iclusig.
Croatian: Nuspojave poput letargije, omaglice i zamagljenog vida povezane su s lijekom Iclusig.
English: OUTER CARTON AND BOTTLE LABEL
Croatian: KUTIJA I NALJEPNICA NA BOCI
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.
Croatian: • 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.
English: • fluid in the thorax (may cause breathing difficulty), nosebleed, difficulty producing voice sounds,
Croatian: • tekućina u prsištu (može uzrokovati otežano disanje), krvarenje iz nosa, poteškoće u nastanku glasa, plućna hipertenzija
English: The secondary efficacy endpoints in CPCML were complete haematological response (CHR) and major molecular response (MMR).
Croatian: Sekundarni ishodi za bolesnike u kroničnoj fazi KML bili su kompletni hematološki odgovor i veliki molekularni odgovor (MMR, engl. major molecular response).
English: • pain in muscles, skeletal system, neck or chest
Croatian: • bol u mišićima, kostima, vratu ili prsištu
English: Occurrence at 45 mg:
Croatian: Pojava uz 45 mg:
English: Periodic safety update reports
Croatian: Periodička izvješća o neškodljivosti
English: A benefit-risk consideration should guide a decision to restart Iclusig therapy (see sections 4.4 and 4.8) after the event is resolved.
Croatian: 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.
English: 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.
Croatian: 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.
English: Method of use
Croatian: Način upotrebe
English: Monitoring for evidence of thromboembolism and vascular occlusion should be performed and Iclusig should be interrupted immediately in case of vascular occlusion.
Croatian: Mora se provoditi praćenje na prisutnost tromboembolije i vaskularne okluzije, a u slučaju vaskularne okluzije liječenje Iclusigom se mora odmah prekinuti.
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.
Croatian: 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.
English: Iclusig contains lactose
Croatian: Iclusig sadrži laktozu
English: INFORMATION IN BRAILLE Outer Carton:
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Kutija:
English: Do not swallow the desiccant canister contained in the bottle.
Croatian: Nemojte progutati spremnik sa sredstvom za sušenje koji se nalazi u boci.
English: • ketoconazole, itraconazole, voriconazole: medicines to treat fungal infections.
Croatian: • ketokonazol, itrakonazol, vorikonazol: lijekovi za liječenje gljivičnih infekcija.
English: Table 7 Efficacy of Iclusig in resistant or intolerant advanced phase CML patients Accelerated Phase CML
Croatian: Tablica 7 Djelotvornost lijeka Iclusig u bolesnika u uznapredovaloj fazi KML koji su rezistentni ili ne podnose lijek Ubrzana faza KML
English: Cytogenetic Response Major (MCyR) a
Croatian: Citogenetički odgovor Značajni(MCyR) a
English: This is a long-term treatment.
Croatian: Liječenje lijekom Iclusig je dugotrajno.
English: Common musculoskeletal pain, neck pain, musculoskeletal chest pain
Croatian: Često muskuloskeletalna bol, bol u vratu, muskuloskeletalna bol u prsištu
English: • lung infection, blood infection, inflammation of hair follicles
Croatian: • upala pluća, infekcija krvi, upala folikula kose
English: Following either a high-fat and low-fat meal, plasma ponatinib exposures (Cmax and AUC) were not different versus fasting conditions.
Croatian: Izloženosti ponatinibu u plazmi (Cmax i AUC) nakon punomasnog i niskomasnog obroka nisu bile različite u odnosu na uvjete natašte.
English: Myelosuppression was generally reversible and usually managed by withholding Iclusig temporarily or reducing the dose (see section 4.2).
Croatian: Mijelosupresija je obično reverzibilna i najčešće prolazi nakon privremenog prestanka primjene lijeka Inclusig ili nakon smanjenja doze (vidjeti dio
English: • 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
Croatian: • 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.
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)
Croatian: 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)
English: • fluid retention
Croatian: • zadržavanje tekućine
English: • you develop heart or blood vessel problems.
Croatian: • ako se jave problemi sa srcem ili krvnim žilama.
English: Achieved MMR at 45 mg (N=63)
Croatian: Postignut MMR pri 45 mg (N=63)
English: Grade 3 pancreatitis
Croatian: Pankreatitis 3. stupnja
English: 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.
Croatian: 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.
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.
Croatian: 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.
English: CP-CML patients who received fewer prior TKIs attained higher cytogenetic, haematological, and molecular responses.
Croatian: Bolesnici u kroničnoj fazi KML koji su prethodno primali manje TKI terapija postigli su bolji citogenetičke, hematološke i molekularne odgovore.
English: Recurrence at 15 mg:
Croatian: Ponovna pojava uz 15 mg:
English: Very common insomnia
Croatian: Vrlo često nesanica
English: How to store Iclusig Keep this medicine out of the sight and reach of children.
Croatian: Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Peak concentrations of ponatinib are observed approximately 4 hours after oral administration.
Croatian: Ponatinib doseže vršnu koncentraciju u plazmi približno četiri sata nakon peroralne primjene.
English: For the standard dose of 45 mg once daily, a 45 mg film-coated tablet is available.
Croatian: Za standardnu dozu od 45 mg jednom dnevno, dostupne su 45 mg filmom obložene tablete.
English: • blurred vision, dry eye
Croatian: • zamagljen vid, suhe oči
English: 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.
Croatian: 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.
English: Common pneumonia, sepsis, folliculitis
Croatian: Često pneumonija, sepsa, folikulitis
English: • tissue swelling in face caused by excess fluid
Croatian: • oticanje tkiva lica uzrokovano prekomjernim nakupljanjem tekućine
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.
Croatian: 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.
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).
Croatian: b CHR: Leukociti ≤ GGN ustanove, ABN ≥1000/mm3, trombociti ≥100,000/mm3, bez blasta ili promijelocita u perifernoj krvi, blasta u koštanoj srži ≤5%, <5% mijelocita plus metamijelocita u perifernoj krvi, bazofila <5% u perifernoj krvi bez uključenosti organa i tkiva van koštane srži (bez hepatomegalije ili splenomegalije).
English: - gamma-glutamyltransferase
Croatian: amilaze alkalne fosfataze gama-glutamiltrasnferaze
English: Very common side effects (affects more than 1 per 10 users):
Croatian: Vrlo česte nuspojave (javljaju se u više od 1 na 10 korisnika):
English: The trial enrolled 449 patients of which 444 were eligible for analysis: 267 CP-CML patients (R/I Cohort: n=203, T315I Cohort: n=64), 83 AP-CML patients (R/I Cohort: n=65, T315I Cohort: n=18), 62 BP-CML (R/I Cohort: n=38, T315I Cohort: n=24) and 32 Ph+ ALL patients (R/I Cohort: n=10, T315I Cohort: n=22).
Croatian: Ispitivanje je uključivalo 449 bolesnika od kojih su 444 bili podobni za analizu: 267 bolesnika u kroničnoj fazi KML (R/I kohorta: n=203, T315I kohorta: N=64) 83 bolesnika u ubrzanoj fazi KML (R/I kohorta: n=65, T315I kohorta: n=18), 62 u blastičnoj fazi KML (R/I kohorta: n=38, T315I
English: Common peripheral arterial occlusive disease, peripheral ischaemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing
Croatian: Često periferna okluzivna arterijska bolest, periferna ishemija, stenoza perifernih arterija, intermitentna klaudikacija, duboka venska tromboza, navale vrućine, naleti crvenila
English: Ponatinib did not adversely affect important developmental parameters in the juvenile toxicity study.
Croatian: U ispitivanjima toksičnosti u mladih štakora ponatinib nije štetno djelovao na važne parametre razvoja.
English: • pain in bones, joints, back, arms or legs, muscle spasms
Croatian: • bolovi u kostima, zglobovima, leđima, rukama ili nogama, grčevi mišića
English: Dose reduction in CP-CML patients
Croatian: Smanjivanje doze u bolesnika u kroničnoj fazi KML
English: Common cerebrovascular accident, cerebral infarction, neuropathy peripheral, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack
Croatian: Često cerebrovaskularni incident, moždani infarkt, periferna neuropatija, letargija, migrena, hiperestezija, hipoestezija, parestezija, tranzitorna ishemijska ataka
English: Handling:
Croatian: Rukovanje:
English: • upper airway infection
Croatian: • infekcija gornjih dišnih putova
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).
Croatian: Preporučuje se oprez prilikom primjene lijeka Iclusig bolesnicima s klirensom kreatinina < 50 ml/min ili bolesnicima u terminalnoj fazi bubrežnog zatajenja (vidjeti dio 4.2).
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.
Croatian: U ispitivanju faze 2, nuspojave arterijske i venske okluzije javile su se u ukupno 23% bolesnika liječenih Iclusigom, s ozbiljnim nuspojavama koje su se javile u 18% bolesnika.
English: Iclusig has not been studied in patients with renal impairment.
Croatian: Iclusig nije ispitivan kod bolesnika s oštećenjem funkcije bubrega.
English: Common pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary hypertension
Croatian: Često plućna embolija, pleuralni izljev, epistaksa, disfonija, plućna hipertenzija
English: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in Iclusig-treated patients.
Croatian: U bolesnika liječenih Iclusigom javile su se arterijske i venske tromboze i okluzije, uključujući i infarkt miokarda sa smrtnom posljedicom, moždani udar, stenozu velikih arterija u mozgu, tešku perifernu vaskularnu bolest, te potrebu za hitnim postupkom revaskularizacije.
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.
Croatian: Medijan vremena do MaHR za bolesnike u ubrzanoj fazi, blastičnoj fazi i Ph+ ALL bio je 21 dan (raspon: 12 do 176 dana), 29 dana (raspon: 12 do 113 dana) i 20 dana (raspon: 11 do 168 dana).
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.
Croatian: Boce od polietilena visoke gustoće (HDPE) s navojnim zatvaračima, sadrže 60 ili 180 filmom obloženih tableta i jedan plastični spremnik s molekularnim sitom kao sredstvom za sušenje.
English: Common dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, weight decreased
Croatian: Često dehidracija, retencija tekućine, hipokalcijemija, hiperglikemija, hiperuricemija, hipofosfatemija, hipertrigliceridemija, hipokalijemija, smanjenje tjelesne težine
English: Iclusig 45 mg film-coated tablets are approximately 9 mm in diameter with "AP4" on one side.
Croatian: Iclusig 45 mg filmom obložene tablete su promjera oko 9 mm s oznakom "AP4" na jednoj strani.
English: No specific studies have been performed to evaluate the effects of gender, age, race, and body weight on ponatinib pharmacokinetics.
Croatian: Intrinzični faktori koji djeluju na farmakokinetiku ponatiniba Nisu provedena ispitivanja za ocjenu utjecaja spola, dobi, rase i tjelesne težine na farmakokinetiku ponatiniba.
English: Common pancreatitis, blood amylase increased, gastrooesophageal reflux disease, stomatitis, dyspepsia, abdominal distension, abdominal discomfort, dry mouth
Croatian: Često pankreatitis, povišena amilaza u krvi, gastroezofagealna refluksna bolest, stomatitis, dispepsija, distenzija abdomena, nelagoda u abdomenu, suha usta
English: Substances that may increase ponatinib serum concentrations
Croatian: Tvari koje mogu povećati serumske koncentracije ponatiniba
English: Calcium decreased
Croatian: Snižen kalcij
English: • the number of blood platelets is reduced.
Croatian: • ako je smanjen broj krvnih pločica (trombocita).
English: Very common fatigue, asthenia, oedema peripheral, pyrexia, pain
Croatian: Vrlo često umor, astenija, periferni edem, pireksija, bol
English: Iclusig 15 mg film-coated tablets are approximately 6 mm in diameter with "A5" on one side.
Croatian: Iclusig 15 mg filmom obložene tablete su promjera oko 6 mm s oznakom "A5" na jednoj strani.
English: Common cardiac failure, myocardial infarction, cardiac failure congestive, coronary artery disease, angina pectoris, pericardial effusion, atrial fibrillation, ejection fraction decreased
Croatian: Često zatajenje srca, infarkt miokarda, kongestivno zatajenje srca, bolest koronarnih arterija, angina pectoris, efuzija perikarda, fibrilacija atrija, smanjena ejekcijska frakcija
English: Duration of use
Croatian: Trajanje primjene
English: Amylase increased
Croatian: Povišena amilaza
English: Substances that may decrease ponatinib serum concentrations
Croatian: Tvari koje mogu smanjiti serumske koncentracije ponatiniba
English: Each film-coated tablet contains 40 mg of lactose monohydrate.
Croatian: Svaka filmom obložena tableta sadrži 40 mg laktoze hidrata.
English: • heart failure (symptoms include: weakness, fatigue, swollen legs)
Croatian: • zatajenje srca (simptomi uključuju: slabost, umor, oticanje nogu)
English: Very common abdominal pain, diarrhoea, vomiting, constipation, nausea, lipase increased
Croatian: Vrlo često bol u abdomenu, proljev, povraćanje, konstipacija, mučnina, povišena lipaza
English: • a history of blood clots in your blood vessels
Croatian: • anamnezu krvnih ugrušaka u krvnim žilama
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.
Croatian: Temeljem Kaplan-Meierovih analiza predviđa se da će 87% (95% CI: [78%-92%]) bolesnika u kroničnoj fazi KML (medijan trajanja liječenja: 866 dana) koji su postigli MCyR i 66% (95% CI: [55%- 75%]) bolesnika u kroničnoj fazi KML koji su postigli MMR održati postignuti odgovor nakon 24 mjeseca.
English: Uncommon poor peripheral circulation, splenic infarction, embolism venous, venous thrombosis
Croatian: Manje često slaba periferna cirkulacija, infarkt slezene, venska embolija, venska tromboza
English: In the phase 2 trial, serious arterial and venous occlusive adverse reactions occurred in 18% of patients (treatment-emergent frequencies).
Croatian: U ispitivanju faze 2, ozbiljne nuspojave arterijske i venske okluzije javile su se u 18% bolesnika (učestalost nuspojava izazvanih liječenjem).
English: Very common upper respiratory tract infection
Croatian: Vrlo često infekcije gornjeg dišnog sustava
English: Dose modifications or interruption of dosing should be considered for the management of haematological and non-haematological toxicities.
Croatian: Za zbrinjavanje hematoloških i nehematoloških toksičnosti potrebno je razmotriti promjenu doze ili prekid doziranja.
English: • increased blood levels of liver and pancreatic enzymes:
Croatian: • povišene razine enzima jetre i gušterače u krvi:
English: R/I Cohort (N=38)
Croatian: R/I kohorta (N=38)
English: cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Croatian: Ph+ ne mogu se uočiti) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
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.
Croatian: Istovremena primjena jednokratne doze lijeka Iclusig od 45 mg s rifampicinom (600 mg dnevno), snažnim CYP3A induktorom, u 19 zdravih dobrovoljaca, uzrokovala je sniženje AUC0-∞ i Cmax ponatiniba za 62% odnosno 42% u usporedbi s onima kad se ponatinib primjenjivao sam.
English: In the phase 2 trial, arterial and venous occlusive adverse reactions have occurred in 23% of patients (treatment-emergent frequencies).
Croatian: U ispitivanju faze 2, nuspojave arterijske i venske okluzije javile su se u 23% bolesnika (učestalost nuspojava izazvanih liječenjem).
English: • indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection.
Croatian: • indinavir, nelfinavir, ritonavir, sakvinavir: lijekovi za liječenje HIV infekcija.
English: At the time of updated reporting with minimum follow-up for all ongoing patients of 27 months, the median duration of MaHR for AP-CML (median duration of treatment: 590 days), BP-CML (median duration of treatment: 89 days), and Ph+ ALL (median duration of treatment: 81 days) patients was estimated as 13.1 months (range: 1.2 to 35.8+ months), 6.1 months (range: 1.8 to 31.8+ months), and 3.3 months (range: 1.8 to 13.0 months), respectively.
Croatian: MaHR za bolesnike s AP-KML (medijan trajanja liječenja: 590 dana), BP-KML (medijan trajanja liječenja: 89 dana), i Ph+ ALL (medijan trajanja liječenja: 81 dan) procijenjen je na 13,1 mjesec (raspon: 1,2 do 35,8+ mjeseci), 6,1 mjesec (raspon: 1,8 do 31,8+ mjeseci) i 3,3 mjeseca (raspon: 1,8 do 13,0 mjeseci).
English: Uncommon myocardial ischemia, acute coronary syndrome, cardiac discomfort, ischemic cardiomyopathy, arteriospasm coronary, left ventricular dysfunction, atrial flutter
Croatian: Manje često ishemija miokarda, akutni koronarni sindrom, srčana nelagoda, ishemijska kardiomiopatija, spazam koronarne arterije, disfunkcija lijeve klijetke, undulacija atrija
English: Common rash pruritic, exfoliative rash, erythema, alopecia, pruritis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, pain of skin, dermatitis exfoliative
Croatian: Često pruritički osip, eksfolijativni osip, eritem, alopecija, pruritus, eksfolijacija kože, noćno znojenje, hiperhidroza, petehije, ekhimoze, bolna koža, eksfolijativni dermatitis
English: c MCyR combines both complete (No detectable Ph+ cells) and partial (1% to 35% Ph+ cells) cytogenetic responses.
Croatian: c MCyR kombinira i kompletne (bez uočenih Ph+ stanica) i parcijalne (1% do 35% Ph+ stanica) citogenetičke odgovore.
English: R/I Cohort (N=65)
Croatian: R/I kohorta (N=65)
English: Uncommon cerebral artery stenosis
Croatian: Manje često stenoza cerebralne arterije
English: Arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions (treatmentemergent frequencies) occurred in 9.6%, 7.3%, and 6.9% of Iclusig-treated patients, respectively.
Croatian: Nuspojave arterijske kardiovaskularne, cerebrovaskularne i periferne vaskularne okluzije (učestalost nuspojava izazvanih liječenjem) javile su se u 9,6%, 7,3%, odnosno 6,9% bolesnika liječenih Iclusigom.
English: • liver tests Liver function tests will be performed periodically, as indicated by your doctor.
Croatian: Kontrole jetrene funkcije treba obavljati povremeno u skladu s uputama liječnika.
English: Pancreatitis Recommended modifications for pancreatic adverse reactions are summarized in Table 2.
Croatian: Pankreatitis Preporučene izmjene doze u slučaju nuspojava na gušterači sažete su Tablici 2.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE24
Croatian: Farmakoterapijska skupina: antineoplastična tvar, inhibitor protein kinaze, ATK oznaka: L01XE24 Ponatinib je snažni opći BCR-ABL inhibitor.